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The study aims to evaluate the prevalence of cardiovascular disease (CVD) among larger-size National Football League (NFL) players currently playing. The results indicate that larger or increased size measured by the body mass index (BMI) was associated with a higher risk of CVD, as can be seen in the case of larger-sized football players.

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.Methods: A parallel-arm experimental study design was used to compare objective sleep apnea measures and patient-reported outcomes in those who received upper airway stimulation approval versus denial in a multinational prospective study (NCT02907398). Wilcoxon rank-sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent upper airway stimulation versus no treatment comparators.Results: A greater reduction in apnea-hypopnea index was observed in those who underwent upper airway stimulation (n = 230, follow-up: 360 ± 171 d) versus no treatment (n = 100, follow-up: 272 ± 278 d), that is, -19.1 ± 15.8 versus -8.1 ± 20.9, respectively, P < 0.001, with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing upper airway stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs. 1.8 ± 3.7, respectively, P < 0.001) and overall sleep-related patient-reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively).Conclusions: Objective and subjective sleep apnea burden was more improved in those receiving upper airway stimulation versus not. Results underscore the need to optimize clinical care pathways focused on effective treatment of patients with obstructive sleep apnea who are not upper airway stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities. [ABSTRACT FROM AUTHOR]

Background: Excessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy. This phase III randomized withdrawal trial evaluated solriamfetol (JZP-110) for the treatment of ES in adults with OSA.Methods: After 2 weeks of clinical titration (n = 174) and 2 weeks of stable dose administration (n = 148), participants who reported improvement on the Patient Global Impression of Change (PGI-C) and had numerical improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) were randomly assigned to placebo (n = 62) or solriamfetol (n = 62) for 2 additional weeks. Coprimary end points were change from weeks 4 to 6 in MWT and ESS.Results: In the modified intention-to-treat population (n = 122), MWT mean sleep latencies and ESS scores improved from baseline to week 4 (from 12.3-13.1 to 29.0-31.7 minutes and from 15.3-16.0 to 5.9-6.4, respectively). From weeks 4 to 6, participants treated with solriamfetol maintained improvements (least squares [LS] mean [SE] changes of -1.0 [1.4] minutes on MWT and -0.1 [0.7] on ESS), whereas participants treated with placebo worsened (LS mean [SE] change of -12.1 [1.3] minutes on MWT and 4.5 [0.7] on ESS); LS mean differences between treatments were 11.2 minutes (95% CI, 7.8-14.6) and -4.6 (95% CI, -6.4 to -2.8) on MWT and ESS, respectively. Fewer participants treated with solriamfetol reported worsening on the PGI-C from weeks 4 to 6 (20% vs 50%; P = .0005). Common adverse events included headache, dry mouth, nausea, dizziness, and insomnia.Conclusions: This study demonstrated maintenance of solriamfetol efficacy and safety over 6 weeks.Trial Registry: ClinicalTrials.gov; No.: NCT02348619; URL: www.clinicaltrials.gov; EudraCT No.: 2014-005515-16. [ABSTRACT FROM AUTHOR]

Rationale: Obstructive sleep apnea (OSA) and depression are common among adults with coronary artery disease (CAD).Objectives: To determine the impact of continuous positive airway pressure (CPAP) treatment on depression in adults with CAD and nonsleepy OSA.Methods: This was a secondary analysis of the RICCADSA (Randomized Intervention with CPAP in CAD and Sleep Apnea) trial, conducted in Sweden between 2005 and 2013. Adults with CAD and nonsleepy OSA (apnea-hypopnea index ≥15/h, and Epworth Sleepiness Scale <10 at baseline) and complete Zung Self-Rating Depression Scale (SDS) questionnaires at baseline, after 3 and 12 months, were included. Participants analyzed in their randomized arm were CPAP (n = 99) or no-CPAP (n = 104). Depression was defined as a Zung SDS score of 50 or greater. The primary outcome was the between-group difference in the absolute change in the SDS score from baseline.Results: No significant between-group differences were observed in SDS scores during follow-up in the entire study sample. Among the 56 participants with an SDS of 50 or greater at baseline (27.6%), the mean (±SD) baseline SDS was 55.0 (±5.5) in the CPAP group, and 53.9 (±4.0) in the no-CPAP group. In the CPAP group, SDS scores decreased at 3 months (47.2 ± 8.2) and 12 months (45.8 ± 7.6), but remained stable in the no-CPAP group at 3 months (53.1 ± 8.0) and 12 months (52.6 ± 8.1) (P = 0.01). The proportion with depression decreased from 30.3% at baseline to 16.2% after 3 months, and to 13.1% after 12 months in the CPAP group, from 25.0% at baseline to 23.1% after 3 months, and to 24.0% after 12 months in the no-CPAP group (P = 0.001). Moreover, there was an association between the duration of CPAP usage (h/night) and the longitudinal decline in SDS score (r = 0.46; P < 0.001). CPAP usage categories (3, 4, and 5 h/night) were significantly associated with improvement in SDS (odds ratio = 3.92, 4.45, and 4.89, respectively) in multivariate analyses adjusted for age, sex, body mass index, left ventricular ejection fraction, apnea-hypopnea index, and Epworth Sleepiness Scale at baseline.Conclusions: Among adults with depression, nonsleepy OSA, and CAD, 3 months of CPAP treatment improved depression scores. The improvement in mood persisted up to 12 months. An on-treatment adjusted analysis confirmed these findings. Clinical trial registered with www.clinicaltrials.gov (NCT00519597). [ABSTRACT FROM AUTHOR]

Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure. [ABSTRACT FROM AUTHOR]

Objective To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline. Results A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced ( P = .01), and sleep-related quality of life as measured by FOSQ significantly improved ( P = .01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea. [ABSTRACT FROM AUTHOR]

Obstructive sleep apnea (OSA) is unrecognized in as high as 80% of patients before surgery. When untreated, OSA increases a surgical patient's propensity for airway collapse and sleep deprivation lending to a higher risk for emergent re-intubation, prolonged recovery time, escalation of care, hospital readmission, and longer length of stay. We have reviewed the evidence regarding diagnostic performance of OSA screening methods and the impact of perioperative management strategies on postoperative complications among patients with diagnosed or suspected OSA who are undergoing orthopedic surgery. We then integrated the data and recommendations from professional society guidelines to develop an evidence-based clinical care pathway to optimize the perioperative management of this surgical population. Successful management of patients with diagnosed or suspected OSA encompass five facets of care: screening, education, airway management, medications, and monitoring. This narrative review revealed two gaps in the evidence to inform management of patients undergoing orthopedic surgery 1) during the perioperative setting to include evidence-based interventions that reduce postoperative complications and 2) after discharge to an unmonitored environment. The clinical care pathway as well as perspectives for future research are discussed. [ABSTRACT FROM AUTHOR]

Objective: To review outcome measures and objective adherence data for patients treated with hypoglossal nerve stimulation (HNS) therapy for moderate to severe obstructive sleep apnea (OSA).Study Design: Case series with chart review.Setting: Academic sleep medicine center.Subjects and Methods: The first 20 implanted patients to complete postoperative sleep laboratory testing were assessed. All patients had moderate to severe OSA, were unable to adhere to positive pressure therapy, and met previously published inclusion criteria for the commercially available implantable HNS system. Data included demographics, body mass index (BMI), apnea-hypopnea index (AHI), Epworth Sleepiness Score (ESS), nightly hours of device usage, and procedure- and therapy-related complications.Results: Mean age was 64.8 ± 12.0 years, with 50% female. Mean BMI was unchanged postoperatively (26.5 ± 4.2 to 26.8 ± 4.5 kg/m(2); P > .05). Mean AHI (33.3 ± 13.0 to 5.1 ± 4.3; P < .0001) and mean ESS (10.3 ± 5.2 to 6.0 ± 4.4; P < .01) decreased significantly. Seventy percent (14/20) of patients achieved a treatment AHI <5, 85% (17/20) an AHI <10, and 95% (19/20) an AHI <15. Average stimulation amplitude was 1.89 ± 0.50 V after titration. Adherence monitoring via device interrogation showed high rates of voluntary device use (mean 7.0 ± 2.2 h/night).Conclusion: For a clinical and anatomical subset of patients with OSA, HNS therapy is associated with good objective adherence, low morbidity, and improved OSA outcome measures. Early results at one institution suggest that HNS therapy can be implemented successfully into routine clinical practice, outside of a trial setting. [ABSTRACT FROM AUTHOR]

Rationale: Lower FEV1 is associated with increased prevalence of atherosclerosis; however, causal mechanisms remain elusive.Objectives: To determine if systemic endothelial dysfunction mediates the association between reduced FEV1 and increased atherosclerosis.Methods: Brachial artery endothelial function, pulmonary function, coronary artery calcium, and carotid plaque were assessed in 231 Pittsburgh SCCOR (Specialized Centers for Clinically Oriented Research) study participants; peripheral arterial endothelial function, pulmonary function, and coronary artery calcium were assessed in 328 HeartSCORE (Heart Strategies Concentrating on Risk Evaluation) study participants.Measurements and Main Results: Lower FEV1 was independently associated with increased atherosclerosis in both cohorts (per 25% lower % predicted FEV1: odds ratio [OR], 1.76; 95% confidence interval [CI], 1.30-2.40; P < 0.001 for carotid plaque in SCCOR participants) (per 25% lower % predicted FEV1: OR, 1.35; 95% CI, 1.02-1.77; P = 0.03 for coronary artery calcium in HeartSCORE participants). Similarly, reduced endothelial function was independently associated with increased atherosclerosis in both cohorts (per SD lower endothelial function: OR, 1.30; 95% CI, 1.01-1.67; P = 0.04 for carotid plaque in SCCOR participants) (per SD lower endothelial function: OR, 1.38; 95% CI, 1.09-1.76; P = 0.008 and OR, 1.41; 95% CI, 1.07-1.86; P = 0.01 for coronary artery calcium in SCCOR and HeartSCORE participants, respectively). However, there was no association between endothelial dysfunction and FEV1, FEV1/FVC, low-attenuation area/visual emphysema, and diffusing capacity in SCCOR participants, and between endothelial dysfunction and FEV1 or FEV1/FVC in HeartSCORE participants (all P > 0.05). Adjusting the association between FEV1 and atherosclerosis for endothelial dysfunction had no impact.Conclusions: Endothelial dysfunction does not mediate the association between airflow limitation and atherosclerosis. Instead, airflow limitation and endothelial dysfunction seem to be unrelated and mutually independent predictors of atherosclerosis. [ABSTRACT FROM AUTHOR]

Objective: To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS).Study Design: A multicenter prospective cohort study.Setting: Industry-supported multicenter academic and clinical setting.Subjects: Participants (n = 116) at 36 months from a cohort of 126 implanted participants.Methods: Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring.Results: Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months.Conclusion: Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA. [ABSTRACT FROM AUTHOR]

The article offers information on rapid eye movement–related sleep-disordered breathing and cardiovascular risk. Topics include reports that an increased risk of cardiovascular disease in participants who receive a diagnosis of sleep-disordered breathing (SDB) when the apnea–hypopnea index (AHI) in both rapid eye movement (REM) and non-REM (NREM) sleep; and examines that observation is biologically plausible because of the unique features of REM related SDB, such as lower lung volumes.

Objectives: This analysis characterized changes in weight in participants with obstructive sleep apnea (OSA) or narcolepsy treated with solriamfetol (Sunosi™) 37.5 (OSA only), 75, 150, or 300 mg/d.Methods: In two 12-week, randomized, placebo-controlled trials and one 1-year open-label extension study, changes in weight were evaluated from baseline to end of study (week 12 or week 40 of the open-label extension [after up to 52 weeks of solriamfetol treatment]) in participants with OSA or narcolepsy.Results: After 12 weeks of solriamfetol treatment, median percent change in weight from baseline across all solriamfetol doses was -0.84%, compared with 0.54% for placebo, in participants with OSA; and -0.07%, compared with 3.08% for placebo, in participants with narcolepsy. After up to 52 weeks of solriamfetol treatment, overall median percent change in weight from baseline was -1.76%, which showed a dose-dependent pattern (75 mg, 0.57%; 150 mg, -1.2%; 300 mg, -2.5%). Results were similar in subgroups of participants with OSA or narcolepsy, with overall median percent changes in weight of -2.2% and -1.1%, respectively. After up to 52 weeks of solriamfetol treatment, the percentage of participants with weight loss ≥5% relative to baseline was 25.7% overall and increased in a dose-dependent manner (75 mg, 4.5%; 150 mg, 17.3%; 300 mg, 32.4%). Results were similar among subgroups of participants with OSA or narcolepsy, with 26.4% and 24.2% of participants experiencing weight loss ≥5%, respectively. No weight-related treatment-emergent adverse events were serious.Conclusions: Solriamfetol treatment was associated with decreases in body weight in a dose-related manner. [ABSTRACT FROM AUTHOR]