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Abstract The influence of naps on tinnitus was systematically assessed by exploring the frequency, clinical and demographic characteristics of this phenomenon. 9,724 data from two different tinnitus databases (Tinnitus Hub: n = 6115; Tinnitus Research Initiative (TRI): n = 3627) were included. After separate analysis of the databases, these results were then compared with each other. In the Tinnitus Hub survey database, a total of 31.1% reported an influence on tinnitus by taking a nap (26.9% in the TRI database), with much more frequent worsening after a nap than improvement (23.0% a little or a lot worse; TRI: 17.7% worse; 8.1% a little or a lot better; TRI: 9.2% better). The influence of napping on tinnitus was associated in both databases with other clinical features, such as the dependence of tinnitus on night quality, stress and somatosensory maneuvers. The present study confirms the clinical observation that more tinnitus sufferers report worsening after a nap than tinnitus sufferers reporting an improvement. It was consistently shown that tinnitus sufferers reporting nap-induced modulation of tinnitus also report more frequently an influence of night sleep on their tinnitus. Further clinical and polysomnographic research is warranted to better understand the interaction between sleep and tinnitus.

ObjectivesWe aimed to evaluate the drug utilization of Ginkgo biloba extract (Gbe), systemic corticosteroids (CSs), and pentoxifylline (PTXF) for the treatment of acute tinnitus by analyzing electronic patient health record data. In addition, we assessed whether the different drug treatments were associated with different frequencies of repeat visits to ear, nose, and throat (ENT) doctors.MethodsThis retrospective cohort study used data from the IQVIA Disease Analyzer (DA) database. It included patients with an initial diagnosis of tinnitus between January 2005 and December 2021, treated by ENT specialists in Germany.ResultsOf 111,629 patients meeting all selection criteria, 51,205 received prescriptions of Gbe, 34,817 of systemic CSs, and 25,607 of PTXF. Gbe prescription was associated with significantly lower odds of a repeat consultation due to tinnitus compared to systemic CSs [odds ratio (OR) 0.91; 95% confidence interval (CI): 0.88–0.95] as well as PTXF (OR 0.74; 95% CI: 0.72–0.77). This association was significant in both men and women and in some age groups.ConclusionGbe is the most frequently ENT specialist-prescribed drug for the treatment of acute tinnitus. It is associated with a reduced likelihood of patients consulting their ENT specialist for tinnitus again compared to systemic CSs and PTXF.

Objectives. The study aimed to assess the relationship of tinnitus with hyperacusis with cognitive impairment as indicated by the Montreal Cognitive Assessment (MoCA) tool. Methods. This multicenter cross-sectional study included individuals with chronic tinnitus from the “Unification of Treatments and Interventions for Tinnitus Patients” (UNITI) database. Participants were recruited from four different tertiary clinical centers located in Athens and Granada (Mediterranean group), as well as Berlin and Regensburg (German group). In total, 380 individuals with a diagnosis of non-pulsatile chronic tinnitus (permanent and constant tinnitus lasting more than 6 months) and no evidence of severe cognitive impairment (MoCA score >22) were enrolled. The evaluation utilized the following tools: MoCA, Tinnitus Handicap Inventory (THI), Hyperacusis Questionnaire (GÜF), Patient Health Questionnaire (PHQ-9), and the European School for Interdisciplinary Tinnitus Research Screening Questionnaire. Results. MoCA scores differed between German and Mediterranean individuals (P

IntroductionTreating major depressive disorder (MDD) with transcranial direct current stimulation (tDCS) devices at home has various logistic advantages compared to tDCS treatment in the clinic. However, preliminary (controlled) studies showed side effects such as skin lesions and difficulties in the implementation of home-based tDCS. Thus, more data are needed regarding the feasibility and possible disadvantages of home-based tDCS.MethodsTen outpatients (23–69 years) with an acute depressive episode were included for this one-arm feasibility study testing home-based tDCS. All patients self-administered prefrontal tDCS (2 mA, 20 min, anodal left, cathodal right) at home on 30 consecutive working days supported by video consultations. Correct implementation of the home-based treatment was analyzed with tDCS recordings. Feasibility was examined by treatment compliance. For additional analyses of effectiveness, three depression scores were used: Hamilton depression rating scale (HDRS-21), Major Depression Inventory (MDI), and the subscale depression of the Depression-Anxiety-Stress Scale (DASS). Furthermore, usability was measured with the user experience questionnaire (UEQ). Tolerability was analyzed by the number of reported adverse events (AEs).ResultsEight patients did not stick to the protocol. AEs were minimal. Four patients responded to the home treatment according to the MDI. Usability was judged positive by the patients.ConclusionsRegular video consultations or other safety concepts are recommended regardless of the number of video sessions actually conducted. Home-based tDCS seems to be safe and handy in our feasibility study, warranting further investigation.

Abstract Background Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. Methods Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. Discussion The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. Trial registration ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

Abstract Mobile applications have gained popularity in healthcare in recent years. These applications are an increasingly important pillar of public health care, as they open up new possibilities for data collection and can lead to new insights into various diseases and disorders thanks to modern data analysis approaches. In this context, Ecological Momentary Assessment (EMA) is a commonly used research method that aims to assess phenomena with a focus on ecological validity and to help both the user and the researcher observe these phenomena over time. One phenomenon that benefits from this capability is the chronic condition tinnitus. TrackYourTinnitus (TYT) is an EMA-based mobile crowdsensing platform designed to provide more insight into tinnitus by repeatedly assessing various dimensions of tinnitus, including perception (i.e., perceived presence). Because the presence of tinnitus is the dimension that is of great importance to chronic tinnitus patients and changes over time in many tinnitus patients, we seek to predict the presence of tinnitus based on the not directly related dimensions of mood, stress level, arousal, and concentration level that are captured in TYT. In this work, we analyzed a dataset of 45,935 responses to a harmonized EMA questionnaire using different machine learning techniques. In addition, we considered five different subgroups after consultation with clinicians to further validate our results. Finally, we were able to predict the presence of tinnitus with an accuracy of up to 78% and an AUC of up to 85.7%.

BackgroundHypersomnia poses major challenges to treatment providers given the limitations of available treatment options. In this context, the application of non-invasive brain stimulation techniques such as transcranial electrical stimulation (tES) may open up new avenues to effective treatment. Preliminary evidence suggests both acute and longer-lasting positive effects of transcranial direct current stimulation (tDCS) on vigilance and sleepiness in hypersomniac patients. Based on these findings, the present study sought to investigate short-term effects of single sessions of tDCS and transcranial random noise stimulation (tRNS) on sleepiness in persons suffering from hypersomnia.MethodsA sample of 29 patients suffering from narcolepsy or idiopathic hypersomnia (IH) was recruited from the Regensburg Sleep Disorder Center and underwent single sessions of tES (anodal tDCS, tRNS, sham) over the left and right dorsolateral prefrontal cortex on three consecutive days in a double-blind, sham-controlled, pseudorandomized crossover trial. The primary study endpoint was the mean reaction time measured by the Psychomotor Vigilance Task (PVT) before and directly after the daily tES sessions. Secondary endpoints were additional PVT outcome metrics as well as subjective outcome parameters (e.g., Karolinska Sleepiness Scale; KSS).ResultsThere were no significant treatment effects neither on objective (i.e., PVT) nor on subjective indicators of sleepiness.ConclusionWe could not demonstrate any clinically relevant effects of single sessions of tDCS or tRNS on objective or subjective measures of sleepiness in patients with hypersomnia. However, we cannot exclude that repeated sessions of tES may affect vigilance or sleepiness in hypersomniac patients.

Abstract Background Low frequency repetitive transcranial magnetic stimulation (rTMS) is commonly used to inhibit pathological hyperactivity of the auditory cortex in tinnitus. Novel and supposedly superior and faster inhibitory protocols such as continuous theta burst stimulation (cTBS) were examined as well, but so far there is not sufficient evidence for a treatment application in chronic tinnitus. rTMS effects in general are dependent on the brain state immediate before stimulation. This feasibility study was designed based on the concept to shift the pathological intrinsic brain state of tinnitus patients via acoustic stimulation (“activate”) and induce inhibitory effects via cTBS (“fire”). Methods Seven tinnitus patients with response in residual inhibition received 10 consecutive daily sessions of a combinatory treatment comprised of 3-minute acoustic stimulation with white noise followed by 600 pulses of cTBS over the left temporo-parietal cortex (activate & fire). A control group of 5 patients was treated parallel to the activate & fire data collection with 10 sessions á 3000 pulses of 1 Hz rTMS over the left temporo-parietal cortex. Results The activate & fire protocol was well tolerated except in one patient with tinnitus loudness increase. This patient was excluded from analyses. No statistical superiority of the activate & fire treatment approach in alleviating tinnitus-related symptoms was evident. Power calculations showed an effect size of 0.706 and a needed sample size of 66 for statistical significant group differences. On a descriptive level the activate & fire group demonstrated a stronger decrease in tinnitus-related symptoms. Conclusion The present feasibility study showed that combining acoustic stimulation with magnetic brain stimulation may be well-tolerable in the majority of patients and represents a promising treatment approach for tinnitus by hypothetically alter the intrinsic state prior to brain stimulation.

IntroductionObsessive-compulsive disorder (OCD) affects 2–3% of the global population, causing distress in many functioning levels. Standard treatments only lead to a partial recovery, and about 10% of the patients remain treatment-resistant. Deep brain stimulation offers a treatment option for severe, therapy-refractory OCD, with a reported response of about 60%. We report a comprehensive clinical, demographic, and treatment data for patients who were treated with DBS in our institution.MethodsWe offered DBS to patients with severe chronic treatment resistant OCD. Severity was defined as marked impairment in functioning and treatment resistance was defined as non-response to adequate trials of medications and psychotherapy. Between 2020 and 2022, 11 patients were implanted bilaterally in the bed nucleus of stria terminalis (BNST). Patients were evaluated with YBOCS, MADRS, GAF, CGI, and WHOQOL-BREF. We performed the ratings at baseline (before surgery), after implantation before the start of the stimulation, after reaching satisfactory stimulation parameters, and at follow-up visits 3, 6, 9, and 12 months after optimized stimulation.ResultsOne patient has retracted his consent to publish the results of his treatment, thus we are reporting the results of 10 patients (5 males, 5 females, mean age: 37 years). Out of our 10 patients, 6 have shown a clear response indicated by a YBOCS-reduction between 42 and 100 percent at last follow-up. One further patient experienced a subjectively dramatic effect on OCD symptoms, but opted afterwards to stop the stimulation. The other 3 patients showed a slight, non-significant improvement of YBOCS between 8.8 and 21.9%. The overall mean YBOCS decreased from 28.3 at baseline to 13.3 (53% reduction) at the last follow-up. The improvement of the OCD symptoms was also accompanied by an improvement of depressive symptoms, global functioning, and quality of life.ConclusionOur results suggest that BNST-DBS can be effective for treatment-resistant OCD patients, as indicated by a reduction in symptoms and an overall improvement in functioning. Despite the need for additional research to define the patients’ selection criteria, the most appropriate anatomical target, and the most effective stimulation parameters, improved patient access for this therapy should be established.

Objective: Tinnitus assessment and outcome measurement are complex, as tinnitus is a purely subjective phenomenon. Instruments used for the outcome measurement of tinnitus in the context of clinical trials include self-report questionnaires, visual analogue or numeric rating scales and psychoacoustic measurements of tinnitus loudness. For the evaluation of therapeutic interventions, it is critical to know which changes in outcome measurement instruments can be considered as clinically relevant. For this purpose, the concept of the minimal clinically important difference (MCID) has been introduced. Study design: Here we performed a literature research in PubMed in order to identify for which tinnitus outcome measurements MCID criteria have been estimated and which of these estimates fulfil the current methodological standards and can thus be considered as established. Results: For most, but not all tinnitus outcome instruments, MCID calculations have been performed. The MCIDs for the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), the Tinnitus Functional Index (TFI) and visual analogue scales (VAS) vary considerably across studies. Psychoacoustic assessments of tinnitus such as loudness matching have not shown sufficient reliability and validity for the use as an outcome measurement. Conclusion: Future research should aim at the confirmation of the available estimates in large samples involving various therapeutic interventions and under the consideration of time intervals and baseline values. As a rule of thumb, an improvement of about 15% can be considered clinically meaningful, analogous to what has been seen in other entirely subjective pathologies like chronic pain.

Abstract More than 10% of the population suffers from tinnitus, which is a phantom auditory condition that is coded within the brain. A new neuromodulation approach to treat tinnitus has emerged that combines sound with electrical stimulation of somatosensory pathways, supported by multiple animal studies demonstrating that bimodal stimulation can elicit extensive neural plasticity within the auditory brain. More recently, in a large-scale clinical trial, bimodal neuromodulation combining sound and tongue stimulation drove significant reductions in tinnitus symptom severity during the first 6 weeks of treatment, followed by diminishing improvements during the second 6 weeks of treatment. The primary objective of the large-scale randomized and double-blinded study presented in this paper was to determine if background wideband noise as used in the previous clinical trial was necessary for bimodal treatment efficacy. An additional objective was to determine if adjusting the parameter settings after 6 weeks of treatment could overcome treatment habituation effects observed in the previous study. The primary endpoint at 6-weeks involved within-arm and between-arm comparisons for two treatment arms with different bimodal neuromodulation settings based on two widely used and validated outcome instruments, Tinnitus Handicap Inventory and Tinnitus Functional Index. Both treatment arms exhibited a statistically significant reduction in tinnitus symptoms during the first 6-weeks, which was further reduced significantly during the second 6-weeks by changing the parameter settings (Cohen’s d effect size for full treatment period per arm and outcome measure ranged from − 0.7 to − 1.4). There were no significant differences between arms, in which tongue stimulation combined with only pure tones and without background wideband noise was sufficient to reduce tinnitus symptoms. These therapeutic effects were sustained up to 12 months after the treatment ended. The study included two additional exploratory arms, including one arm that presented only sound stimuli during the first 6 weeks of treatment and bimodal stimulation in the second 6 weeks of treatment. This arm revealed the criticality of combining tongue stimulation with sound for treatment efficacy. Overall, there were no treatment-related serious adverse events and a high compliance rate (83.8%) with 70.3% of participants indicating benefit. The discovery that adjusting stimulation parameters overcomes previously observed treatment habituation can be used to drive greater therapeutic effects and opens up new opportunities for optimizing stimuli and enhancing clinical outcomes for tinnitus patients with bimodal neuromodulation.

Tinnitus affects a considerable part of the population and develops into a severe disorder in some sufferers. App-based interventions are able to provide low-threshold, cost-effective, and location-independent care for tinnitus patients. Therefore, we developed a smartphone app combining structured counseling with sound therapy and conducted a pilot study to evaluate treatment compliance and symptom improvement (trial registration: DRKS00030007). Outcome variables were Ecological Momentary Assessment (EMA) measured tinnitus distress and loudness and Tinnitus Handicap Inventory (THI) at baseline and final visit. A multiple-baseline design with a baseline phase (only EMA) followed by an intervention phase (EMA and intervention) was applied. 21 patients with chronic tinnitus (≥ 6 months) were included. Overall compliance differed between modules (EMA usage: 79% of days, structured counseling: 72%, sound therapy: 32%). The THI score improved from baseline to final visit indicating a large effect (Cohens d = 1.1). Tinnitus distress and loudness did not improve significantly from baseline phase to the end of intervention phase. However, 5 of 14 (36%) improved clinically meaningful in tinnitus distress (ΔDistress ≥ 10) and 13 of 18 (72%) in THI score (ΔTHI ≥ 7). The positive relationship between tinnitus distress and loudness weakened over the course of the study. A trend but no level effect for tinnitus distress could be demonstrated by a mixed effect model. The improvement in THI was strongly associated with the improvement scores in EMA of tinnitus distress (r = -0.75; 0.86). These results indicate that app-based structured counseling combined with sound therapy is feasible, has an impact on tinnitus symptoms and reduces distress for several patients. In addition, our data suggest that EMA could be used as a measurement tool to detect changes in tinnitus symptoms in clinical trials as has already been shown in other areas of mental health research.

Introduction: Depression in the elderly is an understudied condition. Psychopharmacological and psychotherapeutic approaches suffer from specific difficulties with this patient group. Brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) offer a therapeutic alternative. rTMS remains understudied in this age group when compared with younger patients. Methods: A cohort of 505 patients with depression was analyzed in retrospect concerning their response to rTMS treatment. A total of 15.5% were 60 years old or older, defined as the elderly group of depressed patients. The majority of these were treated with high-frequency protocols over the left dorsolateral prefrontal cortex (DLPFC). For group comparisons, we used Student t-tests or chi-square-tests, depending on the scales of measurement. As measures for effect size, we used Cohen’s d for the relative and absolute change in the HDRS total score. Results: Groups did not differ significantly with respect to baseline depression severity or treatment parameters. In the group of elderly patients, a higher number of females were present. Groups did not differ significantly with respect to treatment efficacy, as indicated by the absolute and relative changes in the HDRS-21 sum score. Elderly patients tended to take higher numbers of mood stabilizers. Elderly patients showed a significantly superior reduction for the item “appetite” and a superior reduction tending towards significance for the item “work and interests”. Conclusions: Antidepressant rTMS treatment showed comparable efficacy for patients above 60 years to that in younger patients. Differences between the age groups concerning amelioration of distinct HDRS single items deserve further investigation.

Abstract Background Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project). Methods/study design This is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. Discussion Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus. Trial registration ClinicalTrials.gov NCT04663828 . Registered on 11 December 2020.

BackgroundChronic tinnitus is an increasing worldwide health concern, causing a significant burden to the health care system each year. The COVID-19 pandemic has seen a further increase in reported cases. For people with tinnitus, symptoms are exacerbated because of social isolation and the elevated levels of anxiety and depression caused by quarantines and lockdowns. Although it has been reported that patients with tinnitus can experience changes in cognitive capabilities, changes in adaptive learning via decision-making tasks for people with tinnitus have not yet been investigated. ObjectiveIn this study, we aim to assess state- and trait-related impairments in adaptive learning ability on probabilistic learning tasks among people with tinnitus. Given that performance in such tasks can be quantified through computational modeling methods using a small set of neural-informed model parameters, such approaches are promising in terms of the assessment of tinnitus severity. We will first examine baseline differences in the characterization of decision-making under uncertainty between healthy individuals and people with tinnitus in terms of differences in the parameters of computational models in a cross-sectional experiment. We will also investigate whether these computational markers, which capture characteristics of decision-making, can be used to understand the cognitive impact of tinnitus symptom fluctuations through a longitudinal experimental design. MethodsWe have developed a mobile app, AthenaCX, to deliver e-consent and baseline tinnitus and psychological assessments as well as regular ecological momentary assessments (EMAs) of perceived tinnitus loudness and a web-based aversive version of a probabilistic decision-making task, which can be triggered based on the participants’ responses to the EMA surveys. Computational models will be developed to fit participants’ choice data in the task, and cognitive parameters will be estimated to characterize participants’ current ability to adapt learning to the change of the simulated environment at each session when the task is triggered. Linear regression analysis will be conducted to evaluate the impacts of baseline tinnitus severity on adapting decision-making performance. Repeated measures linear regression analysis will be used to examine model-derived parameters of decision-making in measuring real-time perceived tinnitus loudness fluctuations. ResultsEthics approval was received in December 2020 from Dublin City University (DCUREC/2021/070). The implementation of the experiments, including both the surveys and the web-based decision-making task, has been prepared. Recruitment flyers have been shared with audiologists, and a video instruction has been created to illustrate to the participants how to participate in the experiment. We expect to finish data collection over 12 months and complete data analysis 6 months after this. The results are expected to be published in December 2023. ConclusionsWe believe that EMA with context-aware triggering can facilitate a deeper understanding of the effects of tinnitus symptom severity upon decision-making processes as measured outside of the laboratory. International Registered Report Identifier (IRRID)PRR1-10.2196/36583

Abstract Tinnitus is an auditory phantom perception in the absence of an external sound stimulation. People with tinnitus often report severe constraints in their daily life. Interestingly, indications exist on gender differences between women and men both in the symptom profile as well as in the response to specific tinnitus treatments. In this paper, data of the TrackYourTinnitus platform (TYT) were analyzed to investigate whether the gender of users can be predicted. In general, the TYT mobile Health crowdsensing platform was developed to demystify the daily and momentary variations of tinnitus symptoms over time. The goal of the presented investigation is a better understanding of gender-related differences in the symptom profiles of users from TYT. Based on two questionnaires of TYT, four machine learning based classifiers were trained and analyzed. With respect to the provided daily answers, the gender of TYT users can be predicted with an accuracy of 81.7%. In this context, worries, difficulties in concentration, and irritability towards the family are the three most important characteristics for predicting the gender. Note that in contrast to existing studies on TYT, daily answers to the worst symptom question were firstly investigated in more detail. It was found that results of this question significantly contribute to the prediction of the gender of TYT users. Overall, our findings indicate gender-related differences in tinnitus and tinnitus-related symptoms. Based on evidence that gender impacts the development of tinnitus, the gathered insights can be considered relevant and justify further investigations in this direction.

Background and aimCOVID-19 is a respiratory disease caused by the new coronavirus SARS-CoV-2, for which the first cases were reported in China, by December 2019. The spectrum of clinical presentations is wide, ranging from asymptomatic cases to a severe acute respiratory syndrome, sometimes with multiple systems involvement. Viral infections, including those related to respiratory virus, may cause hearing loss and, by extent, considering its pathophysiology, tinnitus. A systematic review on inner ear related symptoms in patients with COVID-19 reported 4.5% occurrence rate of tinnitus, with high variance of prevalence between the studies. Our aim is to further explore the relationship between COVID-19 and tinnitus. For this purpose we analyzed a sample of people who had suffered from a COVID-19 infection in the city of Volta Redonda, Brazil. In detail, we compared those with new onset tinnitus during or after the COVID-19 infection with those without tinnitus and those with tinnitus onset before the COVID-19 infection.MethodsFifty-seven patients over 18 years old and previously diagnosed with COVID-19 confirmed by a RT-PCR test were included. Patients were subdivided in three groups: no tinnitus (NT), tinnitus that already existed before COVID-19 (chronic tinnitus, CT) and tinnitus that arose during or after COVID-19 (post-COVID-19 tinnitus, PCT). Data concerning COVID-19 symptoms, drugs prescribed for COVID-19, tinnitus characteristics, comorbidities and other otological symptoms were collected. For all the patients, tonal audiometry and otoacoustic emissions were performed. Tinnitus patients fulfilled the Tinnitus Handicap Inventory (THI) and visual-analog scales (VAS) for loudness and distress. Patients with CT answered a simple question about the worsening of their tinnitus after COVID-19.ResultsPCT was reported by 19.3% of the patients, while 22.8% reported CT. No statistical difference was found between CT and PCT concerning hearing function, tinnitus characteristics and tinnitus distress. There was also no statistically significant difference between PCT and NT with respect to COVID-19 symptoms and pharmacological COVID-19 treatment. Patients with CT reported worsening of their tinnitus after COVID-19.ConclusionAs with other viral infections, inner ear symptoms may be associated with COVID-19. In our sample patients with tinnitus onset before COVID-19 and those with tinnitus onset during or after COVID-19 did not differ significantly in their clinical characteristics and their hearing function, suggesting that tinnitus occurring in the context of a COVID-19 infection is not related to a unique pathophysiological mechanism. The comparison of COVID-19 patients, who developed tinnitus with those who did not develop tinnitus did not reveal any differences in COVID-19 symptoms or COVID-19 treatment. Thus, there was no hint, that a specific expression of COVID-19 is closely related to post COVID-19 tinnitus onset. Although some drugs used to treat tinnitus are known to damage the inner ear cells (especially hydroxychloroquine), we did not see any relationship between the intake of these drugs and tinnitus onset, eventually due to the short prescription time and low doses. Among those patients who had tinnitus before COVID-19 30,8% reported worsening after COVID-19. Overall, tinnitus emerging in the context of a COVID-19 infection seems not to differ from tinnitus unrelated to COVID-19. For further exploring the relationship of tinnitus and COVID-19, large population based studies are warranted.

BackgroundTinnitus is a heterogeneous condition which may be associated with moderate to severe disability, but the reasons why only a subset of individuals is burdened by the condition are not fully clear. Ecological momentary assessment (EMA) allows a better understanding of tinnitus by capturing the fluctuations of tinnitus symptoms, such as distress and loudness, and psychological processes, such as emotional arousal, overall stress, mood, and concentration and how these variables interact over time. Whether any of those variables have an influence over the next day, that is, whether any of these variables are auto- or cross-correlated, is still unanswered.ObjectivesAssess whether behavioral and symptom-related data from tinnitus users from the TrackYourTinnitus (TYT) mobile app have an impact on tinnitus loudness and distress on subsequent days.MethodsAnonymized data was collected from 278 users of the iOS or Android TYT apps between 2014 and 2020. Tinnitus-related distress, tinnitus loudness, concentration level, mood, emotional arousal, and overall stress level were assessed using either a slider or the Wong-Baker Pain FACES scale via a daily survey. Three modeling strategies were used to investigate whether tinnitus loudness and distress are affected by previous days symptoms or psychological processes: auto- and cross correlations, regressions with elastic net regularization, and subgrouping within group iterative multiple model estimation (S-GIMME).ResultsNo autocorrelation or cross-correlation was observed at the group level between the variables assessed. However, application of the regression models with elastic net regularization identified individualized predictors of tinnitus loudness and distress for most participants, with the models including contemporaneous and lagged information from the previous day. S-GIMME corroborated these findings by identifying individualized predictors of tinnitus loudness and distress from the previous day.DiscussionWe showed that tinnitus loudness and tinnitus distress are affected by the contemporaneous and lagged dynamics of behavioral and emotional processes measured through EMA. These effects were seen at the group, and individual levels. The relevance EMA and the implications of the insights derived from it for tinnitus care are discussed, especially considering current trends toward the individualization of tinnitus care.

Introduction: This study aimed to explore whether body mass index (BMI), systolic blood pressure (RR syst), diastolic blood pressure (RR diast) or heart rate (HR) are associated with tinnitus status and/or severity. Methods: To that end, we evaluated the influence of tinnitus status and Tinnitus Handicap Inventory (THI) score on BMI, RR syst, RR diast and HR by comparing data from a large sample of patients presenting to a specialized tertiary referral clinic (N = 1066) with data from a population-based control group (N = 9885) by means of linear models. Results: Tinnitus patients had a significantly lower BMI and higher RR syst, RR diast and HR than non-tinnitus patients; however, the contribution of the case–control status to R2 was very small (0.1%, 0.7%, 1.4% and 0.4%, respectively). BMI had little predictive power for the THI score (higher BMI scores were related to higher THI scores; R2 = 0.5%) and neither RR syst, RR diast, nor HR showed a statistically significant association with THI. Discussion: Our findings suggest that HR, RR and BMI are at most marginally associated with tinnitus status and severity.

Evidence-based medicine (EBM) is generally accepted as the gold standard for high-quality medicine and, thus, for managing patients with tinnitus. EBM integrates the best available scientific information with clinical experience and patient values to guide decision-making about clinical management. To help health care providers and clinicians, the available evidence is commonly translated into medical or clinical guidelines based on a consensus. These involve a systematic review of the literature and meta-analytic aggregation of research findings followed by the formulation of clinical recommendations. However, this approach also has limitations, which include a lack of consideration of individual patient characteristics, the susceptibility of guideline recommendations to material and immaterial conflicts of interest of guideline authors and long latencies till new knowledge is implemented in guidelines. A further important aspect in interpreting the existing literature is that the absence of evidence is not evidence of absence. These circumstances could result in the decoupling of recommendations and their supporting evidence, which becomes evident when guidelines from different countries differ in their recommendations. This opinion paper will discuss how these weaknesses can be addressed in tinnitus.

Summary: Background: Mental health is a public health issue for European young people, with great heterogeneity in resource allocation. Representative population-based studies are needed. The Global Burden of Disease (GBD) Study 2019 provides internationally comparable information on trends in the health status of populations and changes in the leading causes of disease burden over time. Methods: Prevalence, incidence, Years Lived with Disability (YLDs) and Years of Life Lost (YLLs) from mental disorders (MDs), substance use disorders (SUDs) and self-harm were estimated for young people aged 10-24 years in 31 European countries. Rates per 100,000 population, percentage changes in 1990-2019, 95% Uncertainty Intervals (UIs), and correlations with Sociodemographic Index (SDI), were estimated. Findings: In 2019, rates per 100,000 population were 16,983 (95% UI 12,823 – 21,630) for MDs, 3,891 (3,020 - 4,905) for SUDs, and 89·1 (63·8 - 123·1) for self-harm. In terms of disability, anxiety contributed to 647·3 (432–912·3) YLDs, while in terms of premature death, self-harm contributed to 319·6 (248·9–412·8) YLLs, per 100,000 population. Over the 30 years studied, YLDs increased in eating disorders (14·9%;9·4-20·1) and drug use disorders (16·9%;8·9-26·3), and decreased in idiopathic developmental intellectual disability (–29·1%;23·8-38·5). YLLs decreased in self-harm (–27·9%;38·3-18·7). Variations were found by sex, age-group and country. The burden of SUDs and self-harm was higher in countries with lower SDI, MDs were associated with SUDs. Interpretation: Mental health conditions represent an important burden among young people living in Europe. National policies should strengthen mental health, with a specific focus on young people. Funding: The Bill and Melinda Gates Foundation

Objective: To investigate whether a four-week course of neuronavigated intermittent theta burst stimulation (iTBS) of the left dorsolateral prefrontal cortex is superior to the non-neuronavigated F3-EEG method of positioning. Methods: We conducted a single-center, two-arm, randomized and double-blinded study (clinicaltrials.gov NCT03953521). 37 inpatients with an at least moderate depressive episode were randomized to receive either neuronavigated or 10-20-EEG-system based F3 guided iTBS. Both groups received twenty week daily sessions of iTBS while continuing to receive standard-of-care treatment by their ward physicians. For navigated iTBS, we used magnetic resonance imaging to target the border between the anterior and middle third of the middle frontal gyrus considered to represent the left dorsolateral prefrontal cortex (lDLPFC).Differences in the treatment arms were blinded by completely mimicking the procedures of the respective other treatment group. Rating physicians were not involved in the treatment procedure.Primary outcome was defined as the change of the 21-item version of the Hamilton Depression Score (HAMD) from baseline to end of treatment at week 4. Secondary outcomes included HAMD score during the treatment, Patient Health Questionnaire-9, WHO Quality of Life-BREF and Clinical Global Impression. For primary outcome, we used a planned group comparison for the absolute change in the HAMD. For secondary outcome measures we calculated analyses of variance (ANOVAs) with the within-subjects factor time (primary: baseline vs. week 4; secondary: all visits) and the between-subjects factor group (navigated vs. F3 guided group). We also did planned contrasts between both groups for all variables and all treatment and follow-up visits with the aim not to oversee any group differences. For group contrasts we used Student T-tests for metric and chi-square tests for categorial variables. Significance threshold was set to 5% uncorrected for multiple comparisons. Results: Enrolment of 80 patients with interim analysis was planned. Interim analysis was performed after 37 patients (intention to treat). 6 patients dropped out, leaving 31 for analysis. With respect to primary outcome criteria, absolute change in the HAMD did not differ significantly between groups. In accordance, relative change and number of responders and remitters were not significantly different. Overall number of responders was 53% and of remitters was 60%. On a descriptive level, the results favor the clinical effects of the F3 group for the absolute and relative change in the HAMD and the number of responders. Number of remitters were exactly the same for both groups. Therefore, we decided to stop the trial due to the added burden of magnetic resonance imaging and neuronavigated treatment in relation to the effect. Secondary outcomes did also not differ significantly between groups. Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions. Conclusion: We noticed a high antidepressive effect of add-on iTBS treatment to standard inpatient treatment but failed to demonstrate a clinical superiority of neuronavigated localization. The non-navigated, F3 guided iTBS treatment used as a control group may be sophisticated enough to dilute potential added benefits, and the difference between the localization approaches is either negligible or too small to justify the additional efforts of navigation. The effects of concomitant treatment may mask effects, but our patient population reflects clinical reality in an inpatient setting. Further prospective studies are warranted to compare neuronavigated with surface-based approaches.

Abstract Little is known about the trajectory of tinnitus over time. This study addressed (1) how often tinnitus remitted in patients with chronic tinnitus; (2) how subjective reported tinnitus characteristics, such as loudness, laterality, and type and measures of burden, such as tinnitus distress, depression, and quality of life, changes over time; (3) how often tinnitus-specific treatments were undertaken and the prevalence of comorbidities, (4) if the number of treatments and comorbidities were associated to changes in tinnitus distress over time. Data from 388 patients with chronic tinnitus who visited a tertiary tinnitus clinic between 2012 and 2017 were interrogated via a mail survey in 2018. Tinnitus characteristics were measured with the Tinnitus Sample Case History Questionnaire and numeric rating scales; tinnitus distress with Tinnitus Handicap Inventory (THI) and the Tinnitus Questionnaire (TQ), depression with the Major Depression Inventory and Quality of life with the World Health Organisation Quality of Life BREF at both time points and the clinical global impression scale. Comorbidities experienced and undertaken treatments were assessed with an in-house survey. Three participants (0.8% of the sample) reported tinnitus remission between both assessments. A decrease in the THI and TQ, and numeric ratings for tinnitus severity, annoyance, unpleasantness, and discomfort was observed, but no differences in tinnitus characteristics, depression, quality of life or overall health status. 64% presented at least one comorbidity, and 88% sought at least on tinnitus-specific treatment. Common comorbidities were psychological and sleeping problems, and the most common interventions were going to the dentist, taking medications, and wearing hearing aids. Our results suggest that full remission of tinnitus is a rare condition, that tinnitus distress on average decreases over time, and that tinnitus characteristics, quality of life, and depression tend to remain unaltered. The high number of interventions and comorbidities displayed minimal association to the changes in tinnitus distress, highlighting the substantial and durable burden of tinnitus sufferers.

Abstract Background A large proportion of admissions to psychiatric hospitals happen as emergency admissions and many of them occur out of core working hours (during the weekends, on public holidays and during night time). However, very little is known about what determines admission times and whether the information of admission time bears any relevance for the clinical course of the patients. In other words, do admission times correlate with diagnostic groups? Can accumulations of crises be detected regarding circadian or weekly rhythms? Can any differences between workdays and weekends/public holidays be detected? May it even be possible to use information on admission times as a predictor for clinical relevance and severity of the presented condition measured by the length of stay? Methods In the present manuscript we analyzed data derived from 37′705 admissions to the Psychiatric District Hospital of Regensburg located in the Southern part of Germany covering the years 2013 to 2018 with regard to ICD-10 diagnostic groups and admission times. The hospital provides 475 beds for in-patient treatment in all fields of clinical psychiatry including geriatrics and addiction medicine. Results Several core questions could be answered based on our analysis: 1st Our analysis confirms that there is a high percentage of unheralded admissions out of core time showing broad variation. 2nd In contrary to many psychiatrists’ misconceptions the time of admission has no relevant impact on the length of stay in the hospital. 3rd The predictive value of admission time regarding the allocation to ICD-10 diagnostic groups is low explaining only 1% of variability. Conclusions Taken together, our data reveal the enormous variation of admission times of psychiatric patients accounting for the need of adequate and consistent provision of personnel and spatial resources.

BackgroundChronic tinnitus is a clinically multidimensional phenomenon that entails audiological, psychological and somatosensory components. Previous research has demonstrated age and female gender as potential risk factors, although studies to this regard are heterogeneous. Moreover, whilst recent research has begun to identify clinical “phenotypes,” little is known about differences in patient population profiles at geographically separated and specialized treatment centers. Identifying such differences might prevent potential biases in joint randomized controlled trials (RCTs) and allow for population-specific treatment adaptations.MethodTwo German tinnitus treatment centers were compared regarding pre-treatment data distributions of their patient population bases. To identify overlapping as well as center-specific factors, juxtaposition-, similarity-, and meta-data-based methods were applied.ResultsBetween centers, significant differences emerged. One center demonstrated some predictive power of the patients of the other center with regard to questionnaire score after treatment, indicating similarities in treatment response across center populations. Furthermore, adherence to the completion of the questionnaires was found to be an important factor in predicting post-treatment data.DiscussionDifferential age and gender distributions per center should be considered as regards RCT design and individualized treatment planning.

Optimization of dietary intake is an essential component in the multidimensional effort to prevent and manage chronic disease. Recently, demand has increased for nutrition-focused management strategies for chronic tinnitus. The primary aim of this study was to evaluate 10 dietary items for their association with changes in subjective tinnitus severity. A secondary aim was to develop an algorithm to better identify those individuals who might benefit from dietary modification strategies. A total of 5017 anonymous users of the TinnitusTalk forum completed an online survey regarding how various dietary items affected the severity of their tinnitus. Results suggest that, while intake of caffeine [positive effect (PE): 0.4%; negative effect (NE): 16.2%], alcohol (PE: 2.7%; NE: 13.3%, and salt (PE: 0.1%; NE: 9.9%) was most likely to influence tinnitus severity, it did so only for a small proportion of participants and reported effects were most commonly mild. Further, though a classification algorithm was able to leverage participant demographic, comorbidity, and tinnitus characteristics to identify those individuals most likely to benefit from dietary modification above chance levels, further efforts are required to achieve significant clinical utility. Taken together, these results do not support dietary modification as a primary treatment strategy for chronic tinnitus in the general population, though clinically meaningful effects might be observable in certain individuals.

Abstract Several studies emphasized the potential of single and multiple transcranial random noise stimulation (tRNS) sessions to interfere with auditory cortical activity and to reduce tinnitus loudness. It was the objective of the present study to evaluate the use of high-frequency (hf) tRNS in a one-arm pilot study in patients with chronic tinnitus. Therefore, 30 patients received 10 sessions of high frequency tRNS (100-640 Hz; 2 mA; 20 minutes) over the bilateral temporal cortex. All patients had received rTMS treatment for their tinnitus at least 3 months before tRNS. Primary outcome was treatment response (tinnitus questionnaire reduction of ≥5 points). The trial was registered at clinicaltrials.gov (NCT01965028). Eight patients (27%) responded to tRNS. Exactly the same number of patients had responded before to rTMS, but there were only two “double responders” for both treatments. None of the secondary outcomes (tinnitus numeric rating scales, depressivity, and quality of life) was significant when results were corrected for multiple comparisons. tRNS treatment was accompanied by tolerable side effects but resulted in temporal increases in tinnitus loudness in 20% of the cases (2 drop-outs). Our trial showed that hf-tRNS is feasible for daily treatment in chronic tinnitus. However, summarizing low treatment response, increase of tinnitus loudness in 20% of patients and missing of any significant secondary outcome, the use of hf-tRNS as a general treatment for chronic tinnitus cannot be recommended at this stage. Differences in treatment responders between tRNS and rTMS highlight the need for individualized treatment procedures.

Health systems worldwide are challenged by the coronavirus pandemic and all medical specialties have struggle to meet the conflicting requirements for virus containment on the one hand and treatment of other medical conditions on the other. This holds true also for psychiatry. Per se, psychiatric patients are highly vulnerable to suffer from social isolation and loneliness. As a result of the Covid-19 pandemic and lockdown measures, unfortunately, this vulnerability is even further increased. As a part of its pandemic risk management, the outpatient clinic of the Psychiatric District Hospital Regensburg launched an online blog as a means of assisting patients who were required to stay home. Aim of the blog was to stay by patients' side in those uncertain times by offering an online connection to their therapists, by providing important information about the pandemic situation, by offering some ideas on how to build a daily routine and how to meaningfully spend their time at home during the lockdown. We also aimed at involving patients as experts in their own affairs by inviting them to contribute to the blog's shape and content. As a result of coordinated team effort, it was possible to launch a blog within few days, and this was perceived helpful by many patients. Overall, however, patient involvement turned out to be a challenge requiring more attention in future work.