Search

Study Objectives Neurocognitive impairments in comorbid insomnia and sleep apnea (COMISA) are not well documented. We explored neurocognitive functioning and treatment effects in individuals with COMISA as an ancillary study to a randomized clinical trial (RCT). Methods Participants with COMISA (n=45; 51.1% female; mean age=52.07±13.29 years), from a 3-arm RCT combining Cognitive Behavioral Therapy for insomnia (CBT-I) and Positive Airway Pressure (PAP) concurrently (CBT-I+PAP) or sequentially, completed neurocognitive testing at baseline, and post-treatment. Using Bayesian linear mixed models, we estimated effects of CBT-I, PAP, or CBT-I+PAP, compared to baseline, and CBT-I+PAP compared to PAP on 12 metrics across 5 cognitive domains. Results This COMISA sample had worse neurocognitive performance at baseline than reported for insomnia, sleep apnea, and controls in the literature, though short-term memory and psychomotor speed performance appears intact. When comparing PAP to baseline, performance on all measures was better after treatment. Performance after CBT-I was worse compared to baseline, and only performance in attention/vigilance, executive functioning via Stroop interference and verbal memory was better with moderate-high effect sizes and moderate probability of superiority (61-83). Comparisons of CBT-I+PAP to baseline generated results similar to PAP and comparing CBT-I+PAP to PAP revealed superior performance in only attention/vigilance via PVT lapses and verbal memory for PAP. Conclusions Treatment combinations involving CBT-I were associated with poorer neurocognitive performance. These potentially temporary effects may stem from sleep restriction, a component of CBT-I often accompanied by initially reduced total sleep time. Future studies should examine long-term effects of individual and combined COMISA treatment pathways to inform treatment recommendations.

STUDY OBJECTIVES: This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning. METHODS: A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures. RESULTS: A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring. CONCLUSIONS: Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303. CITATION: Tu AY, Crawford MR, Dawson SC, et al. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789–800.

ObjectivePoor sleep is a modifiable risk factor for multiple disorders. Frontline treatments (e.g. cognitive-behavioral therapy for insomnia) have limitations, prompting a search for alternative approaches. Here, we compare manualized Mindfulness-Based Therapy for Insomnia (MBTI) with a Sleep Hygiene, Education, and Exercise Program (SHEEP) in improving subjective and objective sleep outcomes in older adults.MethodsWe conducted a single-site, parallel-arm trial, with blinded assessments collected at baseline, post-intervention and 6-months follow-up. We randomized 127 participants aged 50–80, with a Pittsburgh Sleep Quality Index (PSQI) score ⩾5, to either MBTI (n = 65) or SHEEP (n = 62), both 2 hr weekly group sessions lasting 8 weeks. Primary outcomes included PSQI and Insomnia Severity Index, and actigraphy- and polysomnography-measured sleep onset latency (SOL) and wake after sleep onset (WASO).ResultsIntention-to-treat analysis showed reductions in insomnia severity in both groups [MBTI: Cohen's effect size d = −1.27, 95% confidence interval (CI) −1.61 to −0.89; SHEEP: d = −0.69, 95% CI −0.96 to −0.43], with significantly greater improvement in MBTI. Sleep quality improved equivalently in both groups (MBTI: d = −1.19; SHEEP: d = −1.02). No significant interaction effects were observed in objective sleep measures. However, only MBTI had reduced WASOactigraphy (MBTI: d = −0.30; SHEEP: d = 0.02), SOLactigraphy (MBTI: d = −0.25; SHEEP: d = −0.09), and WASOPSG (MBTI: d = −0.26; SHEEP (d = −0.18). There was no change in SOLPSG. No participants withdrew because of adverse effects.ConclusionsMBTI is effective at improving subjective and objective sleep quality in older adults, and could be a valid alternative for persons who have failed or do not have access to standard frontline therapies.

Comorbid insomnia and sleep apnea (COMISA) are the most common co-occurring sleep disorders and present many challenges to clinicians. This review provides an overview of the clinical challenges in the management of patients with COMISA, with a focus on recent evidence regarding the evaluation and treatment of COMISA. Innovations in the assessment of COMISA have used profile analyses or dimensional approaches to examine symptom clusters or symptom severity that could be particularly useful in the assessment of COMISA. Recent randomized controlled trials have provided important evidence about the safety and effectiveness of a concomitant treatment approach to COMISA using cognitive-behavioral therapy for insomnia (CBT-I) with positive airway pressure (PAP). Furthermore, patient-centered considerations that integrate patient characteristics, treatment preferences, and accessibility to treatment in the context of COMISA are discussed as opportunities to improve patient care. Based on these recent advances and clinical perspectives, a model for using multidisciplinary, patient-centered care is recommended to optimize the clinical management of patients with COMISA.

Objective: To examine the relationship between headaches, naps, and nocturnal sleep in women with chronic migraine (CM) using micro-longitudinal data from diaries and actigraphy. Methods: 20 women with CM and 20 age and sex-matched healthy controls (HC) completed self-report questionnaires, electronic diaries, and wrist actigraphy over a 4-week period. Between-group comparisons were conducted with naps (frequency and duration) as the primary variable of interest. Within-group analyses were conducted on the CM group using hierarchical linear mixed models to examine the temporal relationships between headache severity, sleep behaviors, and sleep parameters. The primary variables of interest were naps (number and duration) and nocturnal sleep efficiency (diary and actigraphy). Results: The CM group reported significantly more days with naps (25.85%) compared to the HC group (9.03%) during the study period (p = .0025). Within-group analyses in CM revealed that greater headache severity was associated with longer nap duration (p = .0037) and longer nap duration was associated with lower sleep efficiency measured using diaries (p = .0014) and actigraphy (p

Sleep difficulties, particularly symptoms of insomnia and circadian disruption, are among the primary complaints of gynecologic cancer survivors before, during, and after treatment. Moreover, difficulty sleeping has been linked to poorer health-related quality of life and elevated symptom burden in this population. Although leading behavioral sleep interventions have demonstrated efficacy among cancer survivors, up to 50% of survivors are non-adherent to these treatments, likely because these interventions require labor-intensive behavior and lifestyle changes. Therefore, there is a need for more effective and acceptable approaches to diminish sleep disturbance among cancer survivors. This manuscript describes the methodology of a two-part study guided by the Multiphase Optimization Strategy (MOST) framework to identify a streamlined behavioral sleep intervention for gynecologic cancer survivors. Three candidate intervention components previously shown to decrease sleep disturbance will be evaluated, including sleep restriction, stimulus control, and systematic bright light exposure. Participants will be adult women with a history of non-metastatic gynecologic cancer who have completed primary treatment and who report current poor sleep quality. Fifteen participants will be recruited for Part 1 of the study, which will utilize qualitative methods to identify barriers to and facilitators of intervention adherence. Results will inform changes to the delivery of the candidate intervention components to promote adherence in Part 2, where 80 participants will be recruited and randomized to one of eight conditions reflecting every possible combination of the three candidate intervention components in a full factorial design. Participants will complete assessments at baseline, post-intervention, and 3-months post-intervention. Part 2 results will identify the combination of candidate intervention components that yields the most efficacious yet efficient 6-week intervention for diminishing sleep disturbance. This is the first known study to apply the MOST framework to optimize a behavioral sleep intervention and will yield a resource-efficient treatment to diminish sleep disturbance, improve health-related quality of life, and decrease symptom burden among gynecologic cancer survivors. ClinicalTrials.gov Identifier: NCT05044975.

Objective/background Knowledge of idiopathic hypersomnia symptomatology derives from clinical case series. Web-based registries provide complementary information by allowing larger sample sizes, with greater geographic and social diversity. Patients/methods Data were obtained from the Hypersomnia Foundation's online registry. Common clinical features of idiopathic hypersomnia and other central disorders of hypersomnolence were queried, for the last thirty days and when symptoms were most severe. Symptoms were compared between idiopathic hypersomnia participants with and without long sleep durations and between participants with idiopathic hypersomnia and those with either form of narcolepsy. Frequency of medication use and residual symptoms on medication were evaluated. Results Five-hundred sixty-three registry respondents were included, with idiopathic hypersomnia (n = 468), narcolepsy type 2 (n = 44), and narcolepsy type 1 (n = 51). “Brain fog,” poor memory, and sleep drunkenness were all present in most idiopathic hypersomnia respondents, with brain fog and sleep drunkenness more commonly endorsed by those with long sleep durations. Eighty-two percent of participants with idiopathic hypersomnia were currently treated with medication, most commonly traditional psychostimulants such as amphetamine salts. Among treated patients, symptoms improved while on medication, but substantial residual hypersomnia symptoms remained. Participants with narcolepsy type 1 were more likely than those with idiopathic hypersomnia to endorse intentional and unintentional daytime naps and automatic behaviors. Conclusions Symptoms of idiopathic hypersomnia extend well beyond excessive daytime sleepiness, and these symptoms frequently persist despite treatment. These findings highlight the importance of online registries in identifying gaps in the use and effectiveness of current treatments.

Objective/Background: Insomnia commonly co-occurs with chronic migraines (CM). Non-pharmacological treatments for insomnia in CM patients remain understudied. This is a proof-of-concept study, which aims to evaluate the feasibility, acceptability, and preliminary efficacy of a digital cognitive behavioral therapy for insomnia (dCBT-I) for individuals with CM and insomnia (CM-I) in the United States. Methods: We recruited 42 females with CM-I symptoms from a U.S.-based observational cohort and from the general population via advertisements. Within a multiple baseline design, participants were randomized to receive dCBT-I after 2, 4, or 6 weeks of completing baseline sleep diaries. DCBT-I was scrutinized against benchmarks for completion rates (≥90% to complete dCBT-I), acceptability (≥80% to find dCBT-I acceptable), and posttreatment changes in insomnia symptoms (≥50% indicating a clinically relevant improvement in their insomnia symptoms). As a secondary measure, we also reported percentage of individuals reverting to episodic migraines. Results: Out of 42 randomized, 35 (83.3%) completed dCBT-I within the 12 weeks provided. Of these completers, 33 (94.3%) reported being satisfied (n = 16) or very satisfied (n = 17) with treatment. Additionally, 65.7% of completers responded to treatment as per universally accepted criteria for insomnia. Lastly, 34% of completers reverted from CM to episodic migraine. Conclusion: This study provides evidence for the feasibility and acceptability of dCBT-I in patients with CM-I complaints. Effects of improving insomnia and migraines were suggested. These results indicate that a randomized controlled trial is needed to determine the efficacy of dCBT-I in CM patients.

Background Sleep problems and depression are highly prevalent in pregnancy. Nocturnal rumination has been linked to insomnia and depression in non-pregnant samples, but remains poorly characterized in pregnancy. This study explored relationships of depression and suicidal ideation with insomnia, short sleep, and nocturnal rumination in mid-to-late pregnancy. Methods In this study, 267 pregnant women were recruited from obstetric clinics and completed online surveys on sleep, depression, and nocturnal rumination. Results Over half (58.4%) of the sample reported clinical insomnia on the Insomnia Severity Index, 16.1% screened positive for major depression on the Edinburgh Postnatal Depression Scale (EPDS), and 10.1% endorsed suicidal ideation. Nocturnal rumination was more robustly associated with sleep onset difficulties than with sleep maintenance issues. Depressed women were at greater odds of sleep onset insomnia (OR = 2.80), sleep maintenance insomnia (OR = 6.50), high nocturnal rumination (OR = 6.50), and negative perinatal-focused rumination (OR = 2.70). Suicidal ideation was associated with depression (OR = 3.64) and negative perinatal-focused rumination (OR = 3.50). A four-group comparison based on insomnia status and high/low rumination revealed that pregnant women with insomnia and high rumination endorsed higher rates of depression (35.6%) and suicidal ideation (17.3%) than good-sleeping women with low rumination (1.2% depressed, 4.9% suicidal). Women with insomnia alone (depression: 3.9%, suicidal: 5.9%) or high rumination alone (depression: 10.7%, suicidal: 7.1%) did not differ from good-sleeping women with low rumination. Conclusions High rumination and insomnia are highly common in mid-to-late pregnancy and both are associated with depression and suicidal ideation. Depression and suicidal ideation are most prevalent in pregnant women with both insomnia and high rumination. ClinicalTrials.gov identifier NCT03596879 .

Non-communicable diseases, including diabetes, are partly responsible for the deceleration of improvements of life expectancy in many countries. Diabetes is also associated with sleep disturbances. Our aim was to determine whether sleep disturbances, particularly in people with diabetes, were associated with increased mortality risk. Data from the UK Biobank were analysed (n = 487,728, mean follow-up time = 8.9 years). The primary exposure was sleep disturbances, assessed through the question: Do you have trouble falling asleep at night or do you wake up in the middle of the night? The primary outcome was mortality. We also dichotomized sleep disturbances into "never/sometimes" versus "usually" (frequently), and combined with the presence/absence of diabetes: 24.2% of participants reported "never/rarely" experiencing sleep disturbances, 47.8% "sometimes" and 28.0% "usually". In age- and sex-adjusted models, frequent sleep disturbances were associated with an increased risk of all-cause mortality (hazard ratio [HR], 1.31; 95% confidence interval [CI], 1.26-1.37), which remained significant in the fully adjusted model (HR 1.13, 95% CI 1.09-1.18). The presence of both diabetes and frequent sleep disturbances was associated with greater risk of all-cause mortality than either condition alone. In the fully adjusted model, the hazard ratio for all-cause mortality was 1.11 (95% CI, 1.07-1.15) for frequent sleep disturbances alone, 1.67 (95% CI, 1.57-1.76) for diabetes alone and 1.87 for both (95% CI, 1.75-2.01). Frequent sleep disturbances (experienced by more than one quarter of the sample) were associated with increased risk of all-cause mortality. Mortality risk was highest in those with both diabetes and frequent sleep disturbances. Complaints of difficulty falling or staying asleep merit attention by physicians.

Objective Mindfulness-based interventions (MBI) have been shown to reduce subjective symptoms of insomnia but the effects on objective measures remain unclear. The purpose of this study was to examine sleep EEG microarchitecture patterns from a randomized controlled trial of Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Therapy for Insomnia (MBTI). Methods Sleep EEG spectral analysis was conducted on 36 participants with chronic insomnia (>6 months) randomized to 8-week MBSR, MBTI, or self-monitoring control (SM). Overnight polysomnography with 6-channel EEG was conducted at baseline, post-treatment, and 6-month follow-up. Spectral power averaged from channels C3/C4 across NREM epochs (excluding N1) was examined for within-group changes and relationships with self-report measures. Results Increases in absolute NREM beta (16–25 Hz) power were observed from baseline to post-treatment (p = .02, d = 0.53) and maintained at 6-month follow-up (p = .01, d = 0.57) in the combined MBI groups, and additionally in the gamma (25–40 Hz) range at follow-up for the MBTI group only. No significant changes in these frequency bands were observed for SM. Following mindfulness intervention, NREM beta was positively associated with Five-Facet Mindfulness (FFM) score (rho = 0.37, p = .091) and negatively associated with Insomnia Severity Index (rho = −0.43, p = .047). Conclusion These results in people with insomnia corroborate prior reports of increased high-frequency sleep EEG power associated with mindfulness training. This change in beta EEG pattern merits further evaluation as a potential marker of the effects of mindfulness meditation on sleep, especially given the paradoxical findings in the context of insomnia. Clinical Trial Registration clinicaltrials.gov , NCT00768781 .

African Americans report higher rates of chronic stress compared to non-Hispanic Whites. Consequently, chronic stress contributes to disproportionately higher rates of poor health outcomes among African Americans. Mindfulness meditation is a well-established and studied strategy to reduce stress and potentially improve health outcomes. However, the practice of mindfulness meditation is largely underutilized in African American communities despite its potential health benefits. In this commentary, we will discuss the relevance of mindfulness interventions, limited research available, reasons for low representation, and cultural adaptations for mindfulness meditation in African American communities. We also provide additional strategies to guide future mindfulness research that target African Americans.

Study Objectives To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia. Methods 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI 7) serving as the clinical endpoints. Results No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure. Conclusions The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.

STUDY OBJECTIVES: The purpose of this study was to evaluate the feasibility and acceptability of a novel cognitive behavioral therapy for hypersomnia (CBT-H) in people with central disorders of hypersomnolence and co-occurring depressive symptoms using a telehealth model for delivery and assessment. METHODS: Thirty-five adults with narcolepsy or idiopathic hypersomnia received a 6-session CBT-H delivered individually or in small groups using videoconferencing. The clinical impact of CBT-H was evaluated using the Patient Health Questionnaire, Patient-Reported Outcomes Measurement Information System measures, Epworth Sleepiness Scale, and other patient-reported outcomes collected online at baseline and posttreatment. Feasibility and acceptability of the intervention and telehealth model was also evaluated using qualitative data collected from exit interviews conducted through videoconferencing. RESULTS: Forty percent of the sample achieved a clinically significant baseline to posttreatment change in depressive symptoms (decrease in Patient Health Questionnaire ≥ 5), which is below the prespecified efficacy benchmark (50% of the sample). The prespecified benchmark for a minimal clinically important difference (Cohen’s d > 0.5) on other psychosocial measures was met only on the Patient-Reported Outcomes Measurement Information System global self-efficacy (d = 0.62) in the total sample. Qualitative data revealed enthusiasm for the accessibility of telehealth delivery and the usefulness of several cognitive and behavioral modules but also revealed opportunities to refine the CBT-H program. CONCLUSIONS: These findings indicate that this new CBT-H program can potentially reduce depressive symptoms and improve self-efficacy in people with central disorders of hypersomnolence. Furthermore, telehealth is a promising model for remote delivery and data collection to enhance participant accessibility and engagement. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Psychosocial Adjunctive Treatment for Hypersomnia (PATH); URL: https://clinicaltrials.gov/ct2/show/NCT03904238; Identifier: NCT03904238. CITATION: Ong JC, Dawson SC, Mundt JM, Moore C. Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study. J Clin Sleep Med. 2020;16(12):2047–2062.

Study Objectives Insomnia is common in older adults, and is associated with poor health, including cognitive impairment and cardio-metabolic disease. Although the mechanisms linking insomnia with these comorbidities remain unclear, age-related changes in sleep and autonomic nervous system (ANS) regulation might represent a shared mechanistic pathway. In this study, we assessed the relationship between ANS activity with indices of objective and subjective sleep quality in older adults with insomnia. Methods Forty-three adults with chronic insomnia and 16 age-matched healthy sleeper controls were studied. Subjective sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), objective sleep quality by electroencephalogram spectral components derived from polysomnography, and ANS activity by measuring 24-h plasma cortisol and norepinephrine (NE). Results Sleep cycle analysis displayed lower slow oscillatory (SO: 0.5–1.25 Hz) activity in the first cycle in insomnia compared to controls. In insomnia, 24-h cortisol levels were higher and 24-h NE levels were lower than controls. In controls, but not in insomnia, there was a significant interaction between NE level during wake and SO activity levels across the sleep cycles, such that in controls but not in insomnia, NE level during wake was positively associated with the amount of SO activity in the first cycle. In insomnia, lower 24-h NE level and SO activity in the first sleep cycle were associated with poorer subjective sleep quality. Conclusion Dysregulation of autonomic activity may be an underlying mechanism that links objective and subjective measures of sleep quality in older adults with insomnia, and potentially contribute to adverse health outcomes.

BACKGROUND: Cancer-related sleep disturbance is common and can adversely affect physical and mental health. Bright light (BL) therapy is a novel intervention that targets sleep by promoting circadian regulation. Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited. The present two-phase pilot study assessed the feasibility and preliminary intended effects of BL therapy on sleep in ovarian and endometrial cancer survivors, and explored biologic and chronobiologic factors that may underlie intervention effects. METHODS: In phase I, focus groups were conducted with 12 survivors and 9 gynecologic oncology clinicians to evaluate and gather feedback about the proposed study. In phase II, a pilot randomized controlled trial was conducted with 18 ovarian or endometrial cancer survivors who were randomized to 1:1 to receive 45 minutes of BL or dim light (DL) for 4 weeks. Participants wore wrist actigraphs, completed sleep diaries and self-report questionnaires, and provided blood, saliva, and urine samples at baseline (T1), post-intervention (T2), and 3-month follow-up (T3). RESULTS: Study procedures were modified according to focus group results. Enrollment, retention, and adherence were all ≥ 80%. Mixed-model ANOVAs demonstrated that the number of nighttime awakenings per actigraphy, and sleep quality, cognitive functioning, and depression per self-report trended towards improvements in the BL condition compared to the DL condition. These variables improved from T1 to T2 before returning to baseline at T3. Effect sizes were generally medium to large. CONCLUSIONS: Study findings suggest that BL therapy is feasible among ovarian and endometrial cancer survivors. It may be an effective, non-pharmacological approach to reduce sleep disturbance and symptom burden in this population.

Objective This observational pilot study examined objective circadian phase and sleep timing in chronic migraine (CM) and healthy controls (HC) and the impact of circadian factors on migraine frequency and severity. Background Sleep disturbance has been identified as a risk factor in the development and maintenance of CM but the biological mechanisms linking sleep and migraine remain largely theoretical. Methods Twenty women with CM and 20 age-matched HC completed a protocol that included a 7 day sleep assessment at home using wrist actigraphy followed by a circadian phase assessment using salivary melatonin. We compared CM vs HC on sleep parameters and circadian factors. Subsequently, we examined associations between dim-light melatonin onset (DLMO), the midpoint of the sleep episode, and the phase angle (time from DLMO to sleep midpoint) with the number of migraine days per month and the migraine disability assessment scale (MIDAS). Results CM and HC did not differ on measures of sleep or circadian phase. Within the CM group, more frequent migraine days per month was significantly correlated with DLMO (r = .49, P = .039) and later sleep episode (r = .47, P = .037). In addition, a greater phase angle (ie, circadian misalignment) was significantly correlated with more severe migraine-related disability (r = .48, P = .042). These relationships remained significant after adjusting for total sleep time. Conclusions This pilot study revealed that circadian misalignment and delayed sleep timing are associated with higher migraine frequency and severity, which was not better accounted for by the amount of sleep. These findings support the plausibility and need for further investigation of a circadian pathway in the development and maintenance of chronic headaches. Specifically, circadian misalignment and delayed sleep timing could serve as an exacerbating factor in chronic migraines when combined with biological predispositions or environmental factors.

Introduction Light avoidance is a common coping behavior of individuals with migraine headaches. It is not known whether timing of light exposure is different in individuals with chronic migraine (CM) compared to those without migraine and how this may relate to headache frequency and severity. We tested this by examining timing of the brightest and darkest light and headaches in women with chronic migraines and healthy controls. Methods Sixteen women with CM (mean age = 33.07) and 18 female healthy controls (HC; mean age = 32.22) completed daily ratings of headache severity (0-10, severity > 2 classified as headache) concurrent with light exposure measured by wrist actigraphy for approximately one month (M=28.00 days, range=21-36). Start time of each day’s 10-hour periods of maximum light (M10) and 5-hour periods of lowest light (L5) were calculated and averaged for each participant. T-tests and Cohen’s d effect sizes were used to compare groups. Pearson correlation coefficients were calculated to examine associations between M10/L5 timing and headache frequency and severity. Results M10 was earlier in the CM group compared to the HC group (07:42±00:47 vs. 08:50±00:58, t(32)=3.69, p=0.0008, d=1.08). The CM group exhibited non-significant trend towards earlier L5 compared to the HC group (12:26±00:48 vs. 01:07±01:03, t(32)=1.89, p=0.0723, d=0.62). Among individuals with CM, later M10 timing was associated with more severe average daily headache (r=0.60, p=0.0136) and more frequent headaches (r=0.55, p=0.0257). Later L5 timing was significantly associated with more severe average daily headache (r=0.66, p=0.0052) and showed a non-significant trend toward association with more frequent headaches (r=0.47, p=0.0686). Conclusion Timing of the greatest light exposure period was earlier in CM compared to HC. Within the CM group, those who had earlier light and dark periods reported lower headache severity and fewer days with headaches. These findings suggest the possibility of a role for the circadian system in chronic migraine. Support This study was supported by grant R21NS081088 from the National Institutes of Health.

Introduction The purpose of this study was to conduct a feasibility trial for a novel cognitive behavioral therapy (CBT-H) aimed at improving health-related quality of life (HRQoL) in people with hypersomnia. Methods Participants were 35 adults (32 female, mean age=32.0 years, SD=12.9) with an established diagnosis of Narcolepsy Type 1 (n=12), Type 2 (n=11), or Idiopathic Hypersomnia (n=12). Participants were assigned to individual (n=19) or group (n=16, 3-5 per group) format of a 6-session, manualized CBT-H, delivered using live videoconferencing. Key components of CBT-H included structuring daytime behaviors (e.g., planned naps), emotion regulation techniques, and energy management strategies. Outcome measures for HRQoL included PROMIS measures for depression, anxiety, self-efficacy, and social isolation. Other clinical outcome measures included the Patient Health Questionnaire (PHQ) and Epworth Sleepiness Scale (ESS). Exit interviews were used to collect qualitative data to inform acceptability of the intervention. Results Intent-to-treat analyses were conducted on the entire sample with the last observation carried forward for 3 participants who did not provide post-treatment data. Paired-samples t-test revealed a significant reduction on PROMIS depression (t[34]=2.05, p=0.0486, d=-0.35), and significant increases on PROMIS general self-efficacy (t[34]=3.64, p=0.0009, d=0.62) and self-efficacy managing social interactions (t[34]=2.14, p=0.0396, d=0.36). Significant reductions were also observed on the ESS (t[34]=2.07, p=0.0458, d=-0.35) and PHQ (t[34]=4.42, p Conclusion These findings support the acceptability of a novel CBT-H delivered using a telehealth model and the feasibility of reducing excessive sleepiness and improving HRQoL, particularly in the domains of self-efficacy and depression, in people with narcolepsy and idiopathic hypersomnia. Support This study was supported by grant 185-SR-17 from the American Sleep Medicine Foundation.

BACKGROUND: Insomnia and depression are highly prevalent perinatal complications. Ruminating on stress is etiologically implicated in both disorders, and ruminating while trying to fall asleep has been linked to insomnia and depression during pregnancy. Incompatible with rumination is everyday mindfulness, i.e., living with intentional and nonjudgmental awareness of internal and external experiences in the present moment. Responding to stress mindfully may protect against stress-related perinatal complications such as insomnia and depression. The present study described the association between everyday mindfulness and nocturnal rumination, and examined whether these trait characteristics were independently related to perinatal insomnia and depression. METHODS: Cross-sectional and secondary analysis of existing data from 65 pregnant women recruited from a multisite hospital in Metro Detroit, MI, USA. Subjects completed online surveys including the Insomnia Severity Index, Edinburgh Postnatal Depression Scale, Presleep Arousal Scale, and the revised Cognitive and Affective Mindfulness Scale. RESULTS: Over half (53.8%) of women screened positive for clinical insomnia and 12.3% screened positive for major depression. Women high in mindfulness, relative to those low in mindfulness, reported less nocturnal rumination (Cohen’s d=1.16), insomnia symptoms (Cohen’s d=1.24), and depressive symptoms (Cohen’s d=1.35). Multivariate linear regression revealed that both mindfulness (β=−.24, p=.03) and rumination (β=.38, p

Importance: Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life. Objectives: To investigate the effect of dCBT for insomnia on functional health, psychological well-being, and sleep-related quality of life and to determine whether a reduction in insomnia symptoms was a mediating factor. Design, Setting, and Participants: This online, 2-arm, parallel-group randomized trial comparing dCBT for insomnia with sleep hygiene education (SHE) evaluated 1711 participants with self-reported symptoms of insomnia. Participants were recruited between December 1, 2015, and December 1, 2016, and dCBT was delivered using web and/or mobile channels plus treatment as usual; SHE comprised a website and a downloadable booklet plus treatment as usual. Online assessments took place at 0 (baseline), 4 (midtreatment), 8 (posttreatment), and 24 (follow-up) weeks. Programs were completed within 12 weeks after inclusion. Main Outcomes and Measures: Primary outcomes were scores on self-reported measures of functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale; range, 10-50; higher scores indicate better health); psychological well-being (Warwick-Edinburgh Mental Well-being Scale; range, 14-70; higher scores indicate greater well-being); and sleep-related quality of life (Glasgow Sleep Impact Index; range, 1-100; higher scores indicate greater impairment). Secondary outcomes comprised mood, fatigue, sleepiness, cognitive failures, work productivity, and relationship satisfaction. Insomnia was assessed with the Sleep Condition Indicator (range: 0-32; higher scores indicate better sleep). Results: Of the 1711 participants included in the intention-to-treat analysis, 1329 (77.7%) were female, mean (SD) age was 48.0 (13.8) years, and 1558 (91.1%) were white. Use of dCBT was associated with a small improvement in functional health compared with SHE (adjusted difference [95% CI] at week 4, 0.90 [0.40-1.40]; week 8, 1.76 [1.24-2.28]; week 24, 1.76 [1.22-2.30]) and psychological well-being (adjusted difference [95% CI] at week 4, 1.04 [0.28-1.80]; week 8, 2.68 [1.89-3.47]; week 24, 2.95 [2.13-3.76]), and with a large improvement in sleep-related quality of life (at week 4, -8.76 [-11.83 to -5.69]; week 8, -17.60 [-20.81 to -14.39]; week 24, -18.72 [-22.04 to -15.41]) (all P Conclusions and Relevance: Use of dCBT is effective in improving functional health, psychological well-being, and sleep-related quality of life in people reporting insomnia symptoms. A reduction in insomnia symptoms mediates these improvements. These results confirm that dCBT improves both daytime and nighttime aspects of insomnia, strengthening existing recommendations of CBT as the treatment of choice for insomnia. Trial Registration: isrctn.org identifier: ISRCTN60530898.

Objective Spousal bereavement is linked to increased mortality and morbidity from inflammatory conditions. It also has a significant impact on sleep disturbances. Evidence from experimental studies indicates that chronic stress may prime individuals to have an exaggerated inflammatory response to acute stress. In this study, we examined the association between self-reported sleep disturbances and inflammation after adjusting for depressive symptoms and determined whether this association varies by bereavement status (bereaved individuals versus controls). Methods Participants included 54 bereaved individuals and 47 controls with a M (SD) age of 67.12 (12.11) years. Inflammation was measured using C-reactive protein. Self-reported sleep disturbances were measured using the Pittsburgh Sleep Quality Index. Depressive symptoms were measured using the Center for Epidemiologic Studies Depression Scale. Results Sleep disturbances were not associated with elevated levels of C-reactive protein in the overall group (B = 0.030, standardized β = 0.122, 95% confidence interval [CI] = -0.027 to 0.087, p = .299) after adjusting for depressive symptoms. Results indicated, however, that bereavement moderated the association between inflammation and sleep disturbances (B = 0.104, β = 0.517, 95% CI = 0.009 to 0.198, p = .032). Stratified analyses demonstrated that these associations differed across groups. Associations were significant among bereaved individuals (B = 0.104, β = 0.406, 95% CI = 0.013 to 0.196, p = .026) and not controls (B = -0.016, β = -0.066, 95% CI = -0.096 to 0.065, p = .690). Conclusions These findings provide preliminary evidence that bereavement moderates the association between self-reported sleep disturbances and inflammation. Future studies should examine the course of sleep disturbances after bereavement and establish whether objective sleep has differential associations with inflammation among bereaved adults.

Study Objectives:To investigate whether sleep perception (SP), defined by the ratio of subjective and objective total sleep time, and habitual sleep time in various sleep disorders may be based on ...

Chronic insomnia disorder is a prevalent condition and a significant proportion of these individuals also have obstructive sleep apnea (OSA). These two sleep disorders have distinct pathophysiology and are managed with different treatment approaches. High comorbidity rates have been a catalyst for emerging studies examining multidisciplinary treatment for OSA comorbid with insomnia disorder. In this article, we describe a randomized clinical trial of Cognitive Behavioral Treatment for insomnia (CBT-I) and Positive Airway Pressure (PAP) for OSA. Participants are randomized to receive one of three treatment combinations. Individuals randomized to treatment Arm A receive sequential treatment beginning with CBT-I followed by PAP, in treatment Arm B CBT-I and PAP are administered concurrently. These treatment arms are compared to a control condition, treatment Arm C, where individuals receive PAP alone. Adopting an incomplete factorial study design will allow us to evaluate the efficacy of multidisciplinary treatment (Arms A & B) versus standard treatment alone (Arm C). In addition, the random allocation of individuals to the two different combined treatment sequences (Arm A and Arm B) will allow us to understand the benefits of the sequential administration of CBT-I and PAP relative to concurrent treatment of PAP and CBT-I. These findings will provide evidence of the clinical benefits of treating insomnia disorder in the context of OSA.

Introduction Poor sleep is a modifiable risk factor for multiple chronic disorders. Mindfulness-based therapies potentially improve sleep by enhancing awareness and acceptance of internal and external experiences, thus reducing pre-sleep hyper-arousal. In this pre-registered, randomized controlled trial, we tested the effect of mindfulness-based treatment for insomnia (MBTI) on subjective sleep quality measures (Pittsburgh Sleep Quality Questionnaire, PSQI) in the elderly. Methods Participants above 50 years old with sleep difficulties (PSQI ≥ 5) (mean (sd) age = 62.0 (6.35), 44 female) attended either an 8-week MBTI (N = 34) or sleep hygiene education and exercise program (SHEEP; N = 35). Before and after the interventions, we collected PSQI, insomnia symptoms and features measures (Pre-Sleep Arousal Scale, PSAS; Insomnia Severity Index, ISI; Dysfunctional Beliefs and Attitudes about Sleep, DBAS-30), mindfulness (Five-Facets Mindfulness Questionnaire, FFMQ), and mood and anxiety (Back Depression Inventory, BDI; State-Trait Anxiety Inventory, STAI). PSQI and PSAS (N = 26 to date) were collected at 6-month follow-up. Data were analysed with repeated-measures ANCOVA with group as a between-subject variable for the first 69 participants who completed the study. Results We observed significant improvement across both groups for sleep measures (PSQI: F1,67=36.442, p Conclusion Preliminary results support MBTI as an accessible but effective behavioural intervention with potential long-term benefits for improving sleep and mood, and reducing cognitive-emotional arousal in the elderly. Support This study was supported by an award from the 7th grant call of the Singapore Millennium Foundation Research Grant Programme

Introduction This study examines the effects of treatment sequences using cognitive-behavioral therapy for insomnia (CBT-I) and continuous positive airway pressure (CPAP) therapy on daytime functioning in people with comorbid insomnia and sleep apnea (COMISA). Methods 118 participants with COMISA (Age=49.99±13.12; 53.4% female) were randomized to one of the three study arms: Arm A- CBT-I followed by CPAP, Arm B- CBT-I concurrent with CPAP, and Arm C- CPAP only. Participants were assessed at four time points [baseline/ start of phase 1 (A1), CPAP titration/ start of phase 2 (A2), 30 days (A3) and 90 days (A4) after CPAP initiation]. This study examined secondary outcome measures of daytime functioning, including the Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale, and Flinders Fatigue Scale (FFS). Results Linear mixed model analyses showed a main effect of time on improving functional outcomes in all measurements, with all p< 0.001. There were also arm by time interactions on FOSQ [F(6, 105.36)=4.21, p=0.001] and FFS scores [F(6, 106.95)=3.10, p=0.008]. Pairwise comparisons with Bonferroni adjustment showed improved FOSQ scores in Arm A from A1 to A2 (p=0.011) and A2 to A3 (p=0.005), Arm B from A2 to A3 (p< 0.001), and Arm C from A2 to A3 (p=0.006). For FFS scores, improvements were shown in Arm A from A1 to A2 (p=0.003), and Arm B from A2 to A3 (p < 0.001). Conclusion The results show daytime functioning improvements in patients with COMISA following CPAP and CBT-I. In addition, CBT-I appears to facilitate improvement in sleepiness-related functional status and daytime fatigue. The findings suggest that the combination of CBT-I and CPAP may have a beneficial effect on daytime functioning in patients with COMISA. Support This study was supported by the National Institutes of Health (R01HL114529).

The goal of this review is to provide an update on the use of mindfulness meditation for the treatment of insomnia, including conceptual models and empirical evidence from randomized controlled trials.A metacognitive model of insomnia has been proposed as a conceptual model to explain the application of mindfulness principles for reducing insomnia-related arousal. Furthermore, the evidence base for mindfulness-based therapies has grown with the results of several randomized controlled trials published in the past three years. Treatment effects appear to be strongest on self-report measures compared to objective measures of sleep.Treatment programs featuring mindfulness meditation appear to be viable treatment options for people with insomnia. Further research is needed to determine who is likely to benefit from mindfulness-based therapies and how these interventions work. Additionally, further work is needed to resolve issues related to the delivery and implementation of mindfulness-based therapies.

OBJECTIVE The aim was to describe the early phases of the progressive development of a lifestyle treatment for sustained remission of the metabolic syndrome (MetS) using the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development as a guide. METHODS Early discovery and design phases produced a 3-component (diet, physical activity, stress), group-based lifestyle treatment with an intensive 6-month phase followed by monthly, participant-led maintenance meetings. In the proof-of-concept phase, 26 participants with the MetS (age 53 ± 7 years, 77% female, and 65% ethnic minority) were recruited in a quasi-experimental design to determine if treatment could achieve the prespecified benchmark of MetS remission in ≥50% at 2.5 years. Exploratory outcomes focused on MetS components, weight, and patient-centered benefits on energy/vitality and psychosocial status. RESULTS MetS remission was achieved in 53.8% after a median of 2.5 years. At 2.5 years, an increase of +15.4% reported eating ≥3 servings of vegetables/day, +7.7% engaged in ≥150 minutes of moderate-to-vigorous physical activity/week; and +11.5% reported experiencing no depression in the past 2 weeks. Weight loss ≥5% was achieved by 38.5%, and energy/vitality, negative affect, and social support improved. Median group attendance over 2.5 years was 73.8%. CONCLUSIONS It is plausible that this lifestyle program can produce a remission in the MetS, sustained through 2.5 years. After refinements to enhance precision and strength, progression to feasibility pilot testing and a randomized clinical trial will determine its efficacy as a cost-effective lifestyle option for managing the MetS in the current health care system. (PsycINFO Database Record

The development of psychological and behavioral therapies over the past several decades has led to what is termed the third wave of psychotherapy, a collection of treatments that adopt a new approach to maladaptive cognitions and target broad, contextualistic goals. Within the field of behavioral sleep medicine, treatments for insomnia have followed a similar evolution, and several emerging therapies, including mindfulness and acceptance-based therapies, have begun to accumulate evidence as effective treatments for this sleep disorder over the past several decades. This paper discusses the historical background of the third wave of psychotherapy, introduces each of the third-wave therapies that have been applied to the treatment of insomnia, and reviews the recent literature to critique the effectiveness of these treatments. Relevant controversies with the third-wave therapies are discussed to inform future directions in insomnia research.

The American Academy of Sleep Medicine (AASM) commissioned five Workgroups to develop quality measures to optimize management and care for patients with common sleep disorders including insomnia. Following the AASM process for quality measure development, this document describes measurement methods for two desirable outcomes of therapy, improving sleep quality or satisfaction, and improving daytime function, and for four processes important to achieving these goals. To achieve the outcome of improving sleep quality or satisfaction, pre- and post-treatment assessment of sleep quality or satisfaction and providing an evidence-based treatment are recommended. To realize the outcome of improving daytime functioning, pre- and post-treatment assessment of daytime functioning, provision of an evidence-based treatment, and assessment of treatment-related side effects are recommended. All insomnia measures described in this report were developed by the Insomnia Quality Measures Workgroup and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with insomnia.

Study Objectives: This study examined empirically derived symptom cluster profiles among patients who present with insomnia using clinical data and polysomnography. Methods: Latent profile analysis was used to identify symptom cluster profiles of 175 individuals (63% female) with insomnia disorder based on total scores on validated self-report instruments of daytime and nighttime symptoms (Insomnia Severity Index, Glasgow Sleep Effort Scale, Fatigue Severity Scale, Beliefs and Attitudes about Sleep, Epworth Sleepiness Scale, Pre-Sleep Arousal Scale), mean values from a 7-day sleep diary (sleep onset latency, wake after sleep onset, and sleep efficiency), and total sleep time derived from an in-laboratory PSG. Results: The best-fitting model had three symptom cluster profiles: "High Subjective Wakefulness" (HSW), "Mild Insomnia" (MI) and "Insomnia-Related Distress" (IRD). The HSW symptom cluster profile (26.3% of the sample) reported high wake after sleep onset, high sleep onset latency, and low sleep efficiency. Despite relatively comparable PSG-derived total sleep time, they reported greater levels of daytime sleepiness. The MI symptom cluster profile (45.1%) reported the least disturbance in the sleep diary and questionnaires and had the highest sleep efficiency. The IRD symptom cluster profile (28.6%) reported the highest mean scores on the insomnia-related distress measures (eg, sleep effort and arousal) and waking correlates (fatigue). Covariates associated with symptom cluster membership were older age for the HSW profile, greater obstructive sleep apnea severity for the MI profile, and, when adjusting for obstructive sleep apnea severity, being overweight/obese for the IRD profile. Conclusions: The heterogeneous nature of insomnia disorder is captured by this data-driven approach to identify symptom cluster profiles. The adaptation of a symptom cluster-based approach could guide tailored patient-centered management of patients presenting with insomnia, and enhance patient care.

Patients with hypersomnia disorders (HD) suffer from debilitating symptoms that result in reduced functioning, depression, anxiety, and overall worse quality of life. Little is known about the need and desire of this population to utilize behavioral sleep medicine (BSM) interventions that focus on psychosocial functioning and quality of life, and there have been limited attempts to develop such interventions. The purpose of this survey study was to gather patient-centered data on engagement in pharmacological and nonpharmacological interventions, the psychosocial impact of HD symptoms on quality of life and mental health, and potential interest in BSM services, such as cognitive behavioral therapy, mindfulness or yoga, and support groups. We obtained responses from 371 individuals with HD (65.2% narcolepsy and 34.8% idiopathic hypersomnia) to an Internet-based survey. Overall, HD patients reported engagement in pharmacological and nonpharmacological interventions, with narcolepsy patients reporting more perceived effectiveness than those with idiopathic hypersomnia. In addition, HD patients reported a strong negative impact on psychosocial functioning, with elevations in depression and anxiety symptoms along with significant impact on functioning and quality of life. The majority (71.7-85.5%) voiced at least some interest in BSM services. These data suggest that there is substantial interest and need for BSM services that focus on assessment and treatment of psychosocial functioning related to HD.

It is widely known that patients with chronic rhinosinusitis (CRS) commonly experience sleep disruption. Many of these patients have the associated diagnosis of obstructive sleep apnea (OSA). However, little is known about the risk factors for developing OSA in the CRS population.To identify the risk factors for OSA in CRS to determine who should be screened for OSA among patients with CRS.We evaluated a large cohort of patients with confirmed diagnostic criteria for CRS. Patient medical records were reviewed to identify those with OSA confirmed by overnight polysomnography. Records were further reviewed for demographic information (age, sex, race, and ethnicity), body mass index, and medical history, including the presence of nasal polyps, asthma, aspirin-exacerbated respiratory disease, allergic rhinitis, and eczema. The number of endoscopic sinus operations, duration of CRS, presence of subjective smell loss, and computed tomography Lund-Mackay score were also ascertained.A total of 916 patients with CRS were included in the study. Implementation of a multivariable regression model for identifying adjusted risk factors revealed that African American patients had a significantly higher risk for OSA than white patients, with an adjusted odds ratio of 1.98 (95% confidence interval, 1.19-3.29). Furthermore, patients with CRS without nasal polyps were at higher risk for OSA, with an odds ratio of 1.63 (95% confidence interval, 1.02-2.61) compared with patients with CRS with nasal polyps.African American patients with CRS were at higher risk for OSA compared with white patients, and this patient group needs to be screened for OSA.

Objective Elevated pre-sleep arousal has been consistently associated with insomnia, yet the cognitive–emotional mechanisms involved in sleep-related arousal remain unclear. The purpose of this study was to identify predictors of pre-sleep arousal and trait hyperarousal from a set of variables that included self-reported affect, sleep-related cognitions, locus of control, and gender. Methods Cross-sectional data were analyzed for 128 participants (89 females) who met criteria for psychophysiological insomnia and completed a set of questionnaires that included the Beliefs and Attitudes about Sleep (BAS), Positive and Negative Affect Schedule (Negative Subscale (nPANAS) and Positive Subscale (pPANAS)), Sleep Locus of Control (SLOC), Pre-Sleep Arousal Scale (PSAS), Hyperarousal Scale (HAS) and demographic information. Step-wise regression was conducted with a set of independent variables, with PSAS and HAS serving as separate dependent variables. Results Trait hyperarousal was associated with higher levels of both negative and positive emotionality, as well as negative beliefs about sleep, in both genders. Pre-sleep arousal was associated with greater negative emotionality and internal sleep locus of control, varying by gender. Among women, high pre-sleep arousal was associated with negative emotionality, while in men greater pre-sleep arousal was associated with an internal sleep locus of control. Conclusion These findings have clinical implications, suggesting that men and women may require different cognitive targets when addressing pre-sleep arousal.

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is the inability to initiate or maintain sleep accompanied by daytime dysfunction. OSA and insomnia co-occur at a high rate, and such patients appear to have distinct clinical features of both disorders. Although empirically supported treatments are now available for OSA and insomnia independently, there are currently no standards or guidelines for how to combine or initiate these treatments for patients who suffer from both sleep disorders. Our goal was to review the literature on current diagnostic considerations, clinical features, pathophysiology, and treatment approaches for patients with OSA and comorbid insomnia. In particular, the potential benefits and challenges of using a multidisciplinary treatment model are discussed, including a research strategy that could inform implementation of pulmonary and behavioral sleep medicine treatments. The research, clinical, and policy implications of treating both OSA and insomnia are discussed with the hope that further activity will establish standards or guidelines for patients with OSA and insomnia.

STUDY OBJECTIVES: The internet provides a pervasive milieu for healthcare delivery. The purpose of this study was to determine the effectiveness of a novel web-based cognitive behavioral therapy (CBT) course delivered by an automated virtual therapist, when compared with a credible placebo; an approach required because web products may be intrinsically engaging, and vulnerable to placebo response. DESIGN: Randomized, placebo-controlled trial comprising 3 arms: CBT, imagery relief therapy (IRT: placebo), treatment as usual (TAU). SETTING: Online community of participants in the UK. PARTICIPANTS: One hundred sixty-four adults (120 F: [mean age 49y (18-78y)] meeting proposed DSM-5 criteria for Insomnia Disorder, randomly assigned to CBT (n = 55; 40 F), IRT placebo (n = 55; 42 F) or TAU (n = 54; 38 F). INTERVENTIONS: CBT and IRT each comprised 6 online sessions delivered by an animated personal therapist, with automated web and email support. Participants also had access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users had access to a moderated social network/community of users. TAU comprised no restrictions on usual care and access to an online sleep diary. MEASUREMENTS AND RESULTS: Major assessments at baseline, post-treatment, and at follow-up 8-weeks post-treatment; outcomes appraised by online sleep diaries and clinical status. On the primary endpoint of sleep efficiency (SE; total time asleep expressed as a percentage of the total time spent in bed), online CBT was associated with sustained improvement at post-treatment (+20%) relative to both TAU (+6%; d = 0.95) and IRT (+6%: d = 1.06), and at 8 weeks (+20%) relative to IRT (+7%: d = 1.00) and TAU (+9%: d = 0.69) These findings were mirrored across a range of sleep diary measures. Clinical benefits of CBT were evidenced by modest superiority over placebo on daytime outcomes (d = 0.23-0.37) and by substantial improved sleep-wake functioning on the Sleep Condition Indicator (range of d = 0.77-1.20). Three-quarters of CBT participants (76% [CBT] vs. 29% [IRT] and 18% [TAU]) completed treatment with SE > 80%, more than half (55% [CBT] vs. 17% [IRT] and 8% [TAU]) with SE > 85%, and over one-third (38% [CBT] vs. 6% [IRT] and 0% [TAU]) with SE > 90%; these improvements were largely maintained during follow-up. CONCLUSION: CBT delivered using a media-rich web application with automated support and a community forum is effective in improving the sleep and associated daytime functioning of adults with insomnia disorder. CLINICAL TRIAL REGISTRATION: ISRCTN - 44615689.

The purpose of this study was to introduce a novel statistical technique called the location-scale mixed model that can be used to analyze the mean level and intra-individual variability (IIV) using longitudinal sleep data.We applied the location-scale mixed model to examine changes from baseline in sleep efficiency on data collected from 54 participants with chronic insomnia who were randomized to an 8-week Mindfulness-Based Stress Reduction (MBSR; n = 19), an 8-week Mindfulness-Based Therapy for Insomnia (MBTI; n = 19), or an 8-week self-monitoring control (SM; n = 16). Sleep efficiency was derived from daily sleep diaries collected at baseline (days 1-7), early treatment (days 8-21), late treatment (days 22-63), and post week (days 64-70). The behavioral components (sleep restriction, stimulus control) were delivered during late treatment in MBTI.For MBSR and MBTI, the pre-to-post change in mean levels of sleep efficiency were significantly larger than the change in mean levels for the SM control, but the change in IIV was not significantly different. During early and late treatment, MBSR showed a larger increase in mean levels of sleep efficiency and a larger decrease in IIV relative to the SM control. At late treatment, MBTI had a larger increase in the mean level of sleep efficiency compared to SM, but the IIV was not significantly different.The location-scale mixed model provides a two-dimensional analysis on the mean and IIV using longitudinal sleep diary data with the potential to reveal insights into treatment mechanisms and outcomes.

Background Previous research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. The majority of people with insomnia, however, seek help because of the functional impact and daytime consequences of poor sleep, not because of sleep discontinuity per se. Although some secondary analyses suggest that dCBT may have wider health benefits, no adequately powered study has investigated these as a primary endpoint. This study specifically aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors. Methods/design We propose a pragmatic, parallel-group, randomised controlled trial of 1000 community participants meeting criteria for insomnia disorder. In the DIALS trial (Digital Insomnia therapy to Assist your Life as well as your Sleep), participants will be randomised to dCBT delivered using web and/or mobile channels (in addition to treatment as usual (TAU)) or to sleep hygiene education (SHE), comprising a website plus a downloadable booklet (in addition to TAU). Online assessments will take place at 0 (baseline), 4 (mid-treatment), 8 (post-treatment), and 24 (follow-up) weeks. At week 25 all participants allocated to SHE will be offered dCBT, at which point the controlled element of the trial will be complete. Naturalistic follow-up will be invited at weeks 36 and 48. Primary outcomes are functional health and well-being at 8 weeks. Secondary outcomes are mood, fatigue, sleepiness, cognitive function, productivity and social functioning. All main analyses will be carried out at the end of the final controlled follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine whether observed changes in functional health and well-being are mediated by changes in sleep. The trial is funded by Big Health Ltd. Discussion This study will be the first large-scale, specifically designed investigation of the health and well-being benefits of CBT for insomnia, and the first examination of the association between CBT-mediated sleep improvement and health status. Trial registration ISRCTN60530898. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1364-7) contains supplementary material, which is available to authorized users.