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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 potential 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 behavior therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in 4 treatment arms with single treatment and 6 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 (https://clinicaltrials.gov/ct2/show/NCT04663828). The trial is ongoing. Date of registration: December 11, 2020. The main RCT analyses will start by the end of December 2022 and will include data from patients who have finished their treatment by the 19th of December 2022.

Context The misrepresentation and distortion of research findings, known as “spin,” has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine. Objective To evaluate the abstracts of RCTs found in the cardiology literature for spin. Methods The authors searched PubMed using a specific string of keywords to identify previously published articles documenting RCTs of cardiovascular treatments in humans. To be included, a cardiology trial had to randomize humans to an intervention, statistically compare 2 or more groups, and have a nonsignificant primary endpoint. Records were excluded if they did not meet these criteria. Data extraction was double-blinded and done using a pilot-tested Google Form. Items extracted from each trial included the title, journal, funding source, comparator arm, primary endpoint, statistical analysis of the primary endpoint, secondary endpoints, statistical analysis of secondary endpoints, and trial registration number (if reported). The 2 authors who screened records for inclusion were then asked whether spin was present in the abstract of the randomized trial. Spin in the title, abstract results, abstract conclusions, and selection of reported endpoints were considered. Results Of the 651 PubMed citations retrieved by our search string, 194 RCTs with a clearly defined primary endpoint were identified. Of these 194 RCTs, 66 trials contained nonsignificant primary endpoints and were evaluated for spin. Of these trials, spin was identified in 18 of the 66 abstracts (27.3%). Conclusions Spin was present in our sample of cardiology RCTs. Spin may influence clinical decision making by creating false impressions of the true validity of a drug or intervention.

Objectives: Daily life behaviour can be studied by smart mobile devices. The current study investigated associations between personality traits and smartphone usage in daily routine. Methods: 526 participants used the Track Your Daily Routine smartphone app (TYDR) for 48 days, on average (SD = 63.2, range 2 to 304). The Big Five Inventory 2 (BFI-2) was deployed to measure personality traits (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness). We analyzed associations between personality traits and two indicators of smartphone usage: number of wakeups per day and session duration. Results: Participants reached for a smartphone more frequently during weekdays with shorter duration of usage compared to weekends. Younger people used their smartphones more often but with a shorter duration than older people. Female participants spent more time using smartphone per session than male participants. Extraversion and neuroticism were associated with more frequent checking of the phone per day while conscientiousness was associated with a shorter duration of the session per day. Conclusions: Frequency and duration of daily smartphone usage is associated with personality traits and participants demographics (age, gender). Implications for future research are discussed.

BackgroundTinnitus is a heterogeneous condition 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 allowing individualized models and by capturing the fluctuations of tinnitus symptoms and other behavioral dynamics as they occur, and therefore minimizing the risk of recollection bias. The TrackYourTinnitus (TYT) mobile app provides a platform for collecting ecologically valid time series data from tinnitus users and can be used to address questions like how mood, concentration, tinnitus distress, or loudness relate 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 TYT app auto- and cross-correlate in different time lags, both within and between individuals.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, overall mood, emotional arousal, and overall stress level were assessed using a 10-point visual analog scale via a daily survey. Auto- and cross-correlations were calculated for participants who used the app for at least 10 consecutive days. Lagged cross-correlation was used to investigate the dynamics of each of these variables over time at the group level, followed by linear regression with elastic net regularization for each user. Additionally, subgrouping within group iterative multiple model estimation (S-GIMME) was used to model the behavioral dynamics at the group, subgroup, and individual levels with data collected from 32 users.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. The finding that a subset of users experienced lagged and contemporaneous dynamics was corroborated by the models from S-GIMME. The models had adequate fits, with both contemporaneous and lagged coefficients obtained for most individuals. Two subgroups were identified, the first consisting of users where both contemporaneous and lagged effects were observed, and a second subgroup consisting of users whose dynamics were mainly of contemporaneous effects.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, subgroup, and individual levels. The relevance EMA and the implications of the insights derived from it for tinnitus care are discussed, especially considering current trends towards the individualization of tinnitus care.

The role of stress and its neuroendocrine mediators in tinnitus is unclear. In this study, we measure cortisol as an indicator of hypothalamus–pituitary–adrenal (HPA) axis alterations and brain-derived neurotrophic factor (BDNF) as a marker of adaptive neuroplasticity in hair of chronic tinnitus patients to investigate relationships with tinnitus-related and psychological factors. Cross-sectional data from chronic tinnitus inpatients were analyzed. Data collection included hair sampling, pure tone audiometry, tinnitus pitch and loudness matching, and psychometric questionnaires. Elastic net regressions with n-fold cross-validation were performed for cortisol (N = 91) and BDNF (N = 87). For hair-cortisol (R2 = 0.10), the strongest effects were sampling in autumn and body-mass index (BMI) (positive), followed by tinnitus loudness (positive) and smoking (negative). For hair-BDNF (R2 = 0.28), the strongest effects were hearing aid use, shift work (positive), and tinnitus loudness (negative), followed by smoking, tinnitus-related distress (Tinnitus Questionnaire), number of experienced traumatic events (negative), and physical health-related quality of life (Short Form-12 Health Survey) (positive). These findings suggest that in chronic tinnitus patients, higher perceived tinnitus loudness is associated with higher hair-cortisol and lower hair-BDNF, and higher tinnitus-related distress with lower hair-BDNF. Regarding hair-BDNF, traumatic experiences appear to have additional stress-related effects, whereas hearing aid use and high physical health-related quality of life appear beneficial. Implications include the potential use of hair-cortisol and hair-BDNF as biomarkers of tinnitus loudness or distress and the need for intensive future research into chronic stress-related HPA axis and neuroplasticity alterations in chronic tinnitus.

Gender constitutes a major factor to consider when tailoring subtype-based therapies for tinnitus. Previous reports showed important differences between men and women concerning basic perceptual tinnitus characteristics (i.e., laterality, frequency, tinnitus loudness) as well as psychological reactions linked to this condition. Therapeutic approaches based on acoustic stimulation involve processes beyond a pure masking effect and consist of sound presentation temporarily altering or alleviating tinnitus perception via residual and/or lateral inhibition mechanisms. Presented stimuli may include pure tones, noise, and music adjusted to or modulated to filter out tinnitus pitch and therefore trigger reparative functional and structural changes in the auditory system. Furthermore, recent findings suggest that in tonal tinnitus, the presentation of pitch-adjusted sounds which were altered by a 10Hz modulation of amplitude was more efficient than unmodulated stimulation. In this paper, we investigate sex differences in the outcome of different variants of acoustic stimulation, looking for factors revealing predictive value in the efficiency of tinnitus relief.

More research, including a randomized controlled trial, is needed to further investigate the the combined treatment and gain better understanding of the treatment mechanisms.

Background Tinnitus is the result of aberrant neuronal activity. As a novel treatment form, neuromodulation is used to modify neuronal activity of brain areas involved in tinnitus generation. Among the different forms of electric stimulation, transcranial random noise stimulation (tRNS) has been shown to be a promising treatment option for tinnitus. In addition, recent studies indicate that the reduction in tinnitus can be more pronounced when different modalities of stimulation techniques are combined (“bimodal stimulation”). TRNS can be used in combination with acoustic stimulation (AS), a further treatment option recognized in the literature. The aim of the proposed study is to investigate whether simultaneous tRNS and AS improve levels of tinnitus loudness and distress. Methods The intervention consists of bilateral high-definition tRNS (HD-tRNS) over the auditory cortex combined with the application of AS which is studied in a crossover design. The visits will be performed in 26 sessions. There will be 20 treatment sessions, divided into two blocks: active and sham HD-tRNS. Within the blocks, the interventions are divided into group A: HD-tRNS and AS, and group B: HD-tRNS alone. Furthermore, in addition to the assessments directly following the intervention sessions, there will be six extra sessions performed subsequently at the end of each block, after a period of some days (follow-ups 1 and 2) and a month after the last intervention (C). Primary outcome measures are analog scales for evaluation of subjective tinnitus loudness and distress, and the audiological measurement of minimum masking level (MML). Secondary outcome measures are brain activity as measured by electroencephalography and standardized questionnaires for evaluating tinnitus distress and severity. Discussion To the best of our knowledge, this is the first study which uses HD-tRNS combined with AS for tinnitus treatment. The crossover design permits the comparison between HD-tRNS active vs. sham and with vs. without AS. Thus, it will be possible to evaluate the efficacy of the combined approach to HD-tRNS alone. In addition, the use of different objective and subjective evaluations for tinnitus enable more reliable and valid results. Trial registration Swiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch: SNCTP000004051); and ClinicalTrials.gov (clinicaltrials.gov: NCT04551404).

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 intervention 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 counselling, 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

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.

Acoustic stimulation was shown to be effective in short-term suppression of tinnitus. However, tinnitus cannot be suppressed in all patients. Recent insights from mental health research suggests that personality traits may be important factors in prediction of treatment outcomes or improvement of tinnitus over time. No previous acoustic stimulation study investigated the effects of personality traits on tinnitus suppression and rating of sound stimuli.The aim of this study was therefore to examine whether personality is capable to predict tinnitus suppression in chronic tinnitus patients as well as related emotional stimulus evaluation.Personality data (Big Five Index 2; BFI-2) of two acoustic stimulation experiments were pooled for this analysis. Both experiments were conducted at the University of Regensburg, Germany in the time period between April 2018 and October 2019 and consisted of individual designed noise and amplitude modulated tones matched to the participants' tinnitus pitch. Logistic regressions or linear mixed effect models were performed with tinnitus suppression as well as valence and arousal data as dependent variables and BFI-2 personality dimensions as predictors.28% of the participants showed pronounced short-term tinnitus suppression after acoustic stimulation (50% reduction in subjective tinnitus loudness). Analyzing BFI-2 data, no significant impact of the big five personality traits (neuroticism, agreeableness, extraversion, conscientiousness, openness) were found, neither on acoustic tinnitus suppression, nor on emotional stimulus evaluation, namely arousal.Personality was not shown to be a predictive factor, neither for acoustic stimulation, nor for emotional reaction to stimuli sounds in our studies. However, since tinnitus cannot be suppressed by acoustic stimulation in all patients, future studies should investigate other explaining factors such as patient-related or (neuro)physiological characteristics.

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.

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.

In this study we analyzed psychometric data of 107 individuals who suffer from chronic subjective tinnitus. In particular, we elucidated the relationship between tinnitus-related distress, psychological comorbidities, age, and hearing, and the performance in cognitive concentration and interference tests. Previous research has provided first evidence that individuals with tinnitus may have deficits in cognitive tasks. The present study aimed at extending former research by investigating the relationship between tinnitus distress and cognition. Statistical analyses comprised correlation and regression approaches. We observed a significant relationship between tinnitus distress (tinnitus score, TQ), age and hearing loss and the performance in tests on selective and sustained attention (d2 test) and cognitive interference (Stroop test). Tinnitus distress was identified as the most important predictor of cognitive performance (additionally age for cognitive interference). For other psychometric variables (perceived stress, PSQ; self-efficacy, optimism and pessimism, SWOP) and hearing loss we could not find any meaningful relationship with cognitive performance. The results clearly point to a (currently non-causal) relationship between cognitive skills and distress of tinnitus-related symptoms. Furthermore, the influence of age is noteworthy as this finding implies that with increasing age an appropriate coping with aversive tinnitus symptoms based on proper cognitive functions and age-related hearing dysfunctions, namely inhibition, may become more difficult. Hence, it is suggested to consider cognitive tests as a supplementary measurement in clinical assessment of tinnitus and to raise awareness for the impairing influence of tinnitus on cognition in daily life.

OBJECTIVE: To investigate oscillatory brain activity changes following acoustic stimulation in tinnitus and whether these changes are associated with behavioral measures of tinnitus loudness. Moreover, differences in ongoing brain activity between individuals with and without residual inhibition (RI) are examined (responders vs. non-responders). METHODS: Three different types of noise stimuli were administered for acoustic stimulation in 45 tinnitus patients. Subjects resting state brain activity was recorded before and after stimulation via EEG alongside with subjective measurements of tinnitus loudness. RESULTS: Delta, theta and gamma band power increased, whereas alpha and beta power decreased from pre to post stimulation. Acoustic stimulation responders exhibited reduced gamma and a trend for enhanced alpha activity with the latter localized in the right inferior temporal gyrus. Post stimulation, individuals experiencing RI showed higher theta, alpha and beta power with a peak power difference in the alpha band localized in the right superior temporal gyrus. Neither correlations with behavioral tinnitus measures nor stimulus-specific changes in EEG activity were present. CONCLUSIONS: Our observations might be indicative of trait-specific forms of oscillatory signatures in different subsets of the tinnitus population related to acoustic tinnitus suppression. SIGNIFICANCE: Results and insights are not only useful to understand basic neural mechanisms behind RI but are also valuable for general neural models of tinnitus.

Background: Tinnitus suppression following acoustic stimulation is a well-known phenomenon also termed residual inhibition (RI). Some individuals may experience prolonged RI (PRI), which can last for several hours or even days, after a single short-term acoustic stimulation. Exact mechanisms of this phenomenon are unknown and current evidence anecdotal. Objectives: The aim of our report is to collect, present, and discuss cases of PRI from our studies on acoustic stimulation in tinnitus with the aim to better understand this phenomenon as well as its implications for individualized treatments. Methods: We pooled cases of PRI from four of our studies with a total sample size of n = 130. The criterion was set on a PRI duration which is at least sustained twice as long as the acoustic stimulation duration. Results: We report a total number of about 5% of all participants experiencing some form of PRI, with rates of 3%–7% across the individual studies. PRI lasted from 20 min up to several days and was induced by the first stimulus in four out of six cases. Four out of six individuals experiencing PRI were female and PRI mostly occurred when acoustic stimuli were matched to the frequency or type of the tinnitus. Conclusion: PTS seems to be elicitable in a small subset of tinnitus patients which could inform future individualized treatment options. Future studies should investigate if and how identified factors like stimulus type, position, sex, and chronification grade uphold experimental scrutiny. We propose that the set of methods is furthermore extended with neurophysiology in particular.

Background Acoustic stimulation was shown to be effective in short-term suppression of tinnitus. However, tinnitus cannot be suppressed in all patients. Recent insights from mental health research suggests that personality traits may be important factors in prediction of treatment outcomes or improvement of tinnitus over time. No previous acoustic stimulation study investigated the effects of personality traits on tinnitus suppression and rating of sound stimuli. Objectives The aim of this study was therefore to examine whether personality is capable to predict tinnitus suppression in chronic tinnitus patients as well as related emotional stimulus evaluation. Methods Personality data (Big Five Index 2; BFI-2) of two acoustic stimulation experiments were pooled for this analysis. Both experiments were conducted at the University of Regensburg, Germany in the time period between April 2018 and October 2019 and consisted of individual designed noise and amplitude modulated tones matched to the participants' tinnitus pitch. Logistic regressions or linear mixed effect models were performed with tinnitus suppression as well as valence and arousal data as dependent variables and BFI-2 personality dimensions as predictors. Results 28% of the participants showed pronounced short-term tinnitus suppression after acoustic stimulation (50% reduction in subjective tinnitus loudness). Analyzing BFI-2 data, no significant impact of the big five personality traits (neuroticism, agreeableness, extraversion, conscientiousness, openness) were found, neither on acoustic tinnitus suppression (pmin = 0.18, statmax = 0.29), nor on emotional stimulus evaluation, namely arousal (pmin = 0.07, statmax = 0.22) or valence (pmin = 0.12, statmax = 1.60). Conclusion Personality was not shown to be a predictive factor, neither for acoustic stimulation, nor for emotional reaction to stimuli sounds in our studies. However, since tinnitus cannot be suppressed by acoustic stimulation in all patients, future studies should investigate other explaining factors such as patient-related or (neuro)physiological characteristics.

Magneto- and electroencephalography (M/EEG) investigations in tinnitus patients demonstrated anomalous oscillatory brain activity patterns compared to healthy controls. A well-established phenomenon in tinnitus is the possibility to temporary suppress tinnitus following acoustic stimulation, which is termed residual inhibition (RI). The few former neurophysiological investigations of RI reported partly conflicting results hampering consensus on tinnitus-specific brain activity and basic neural models.Hence, our objective was to investigate RI-specific oscillatory brain activity changes and whether these changes can be associated with behavioral measures of tinnitus loudness. Further, contrasts between acoustic stimulation responders and non-responders provide further insights in RI-related spontaneous brain activity.Three different types of noise stimuli were administered for acoustic stimulation in 45 tinnitus patients. Subjects resting state brain activity was recorded before and during RI via EEG alongside with subjective measurements of tinnitus loudness.On the whole-group level, tinnitus-unspecific changes were observed which fit established knowledge about basic neural responses after acoustic stimulation. Responder non-responder contrasts revealed differences in alpha and gamma band activity in line with the proposed neural models for oscillatory brain activity in tinnitus. Further analysis of sample characteristics demonstrated divergences between responders and nonresponders notably for tinnitus duration. During RI, distinct differences between responders and non-responders were exclusively observed for alpha band activity in auditory cortical areas. Neither correlations of behavioral tinnitus measures nor differences between stimulus-induced changes in ongoing brain activity could be detected.Taken together, our observations might be indicative of trait-specific forms of oscillatory signatures in different subsets and chronification grades of the tinnitus population possibly related to acoustic tinnitus suppression. Results and insights are not only useful to understand basic neural mechanisms behind RI but are also valuable for general neural models of tinnitus.HighlightsResidual inhibition provides a key method to study the basic mechanisms of tinnitus.We compared residual inhibition EEG activity between responders and non-responders.In responders, the alpha activity in auditory areas was increased during tinnitus suppression.Results and insights are valuable for understanding the neural mechanisms behind acoustic tinnitus suppression.

Background: Alpha/delta neurofeedback has been shown to be a potential treatment option for chronic subjective tinnitus. Traditional neurofeedback approaches working with a handful of surface electrodes have been criticized, however, due to their low spatial specificity. Objective: The purpose of this study was to evaluate an innovative tomographic neurofeedback protocol that combines neural activity measured across the whole scalp with sLORETA source estimation. Methods: Forty-eight tinnitus patients participated in 15 neurofeedback training sessions as well as extensive pre, post, and follow-up testing. Patients were randomly assigned to either a tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF) group. Main outcome measures of this study were defined as tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands. Results: For both groups a significant reduction of tinnitus-related distress and tinnitus loudness was found. While distress changes remained persistent irrespective of group, loudness levels returned to baseline in the follow-up period. No significant between-group differences between the 2 neurofeedback applications (TONF vs. NTNF) were found, which suggests a similar contribution to symptom improvement. The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period. This effect was found irrespective of group on both surface and source levels with no meaningful differences between the 2 groups. Conclusions: Our study shows that a tomographic alpha/delta protocol should be considered a promising addition to tinnitus treatment but that more individually specific neurofeedback protocols should be developed.

BACKGROUND Modern smartphones contain sophisticated high-end hardware features, offering high computational capabilities at extremely manageable costs and have undoubtedly become an integral part in users' daily life. Additionally, smartphones offer a well-established ecosystem that is easily discoverable and accessible via the marketplaces of differing mobile platforms, thus encouraging the development of many smartphone apps. Such apps are not exclusively used for entertainment purposes but are also commonplace in health care and medical use. A variety of those health and medical apps exist within the context of tinnitus, a phantom sound perception in the absence of any physical external source. OBJECTIVE In this paper, we shed light on existing smartphone apps addressing tinnitus by providing an up-to-date overview. METHODS Based on PRISMA guidelines, we systematically searched and identified existing smartphone apps on the most prominent app markets, namely Google Play Store and Apple App Store. In addition, we applied the Mobile App Rating Scale (MARS) to evaluate and assess the apps in terms of their general quality and in-depth user experience. RESULTS Our systematic search and screening of smartphone apps yielded a total of 34 apps (34 Android apps, 26 iOS apps). The mean MARS scores (out of 5) ranged between 2.65-4.60. The Tinnitus Peace smartphone app had the lowest score (mean 2.65, SD 0.20), and Sanvello—Stress and Anxiety Help had the highest MARS score (mean 4.60, SD 0.10). The interrater agreement was substantial (Fleiss κ=0.74), the internal consistency was excellent (Cronbach α=.95), and the interrater reliability was found to be both high and excellent—Guttman λ6=0.94 and intraclass correlation, ICC(2,k) 0.94 (95% CI 0.91-0.97), respectively. CONCLUSIONS This work demonstrated that there exists a plethora of smartphone apps for tinnitus. All of the apps received MARS scores higher than 2, suggesting that they all have some technical functional value. However, nearly all identified apps were lacking in terms of scientific evidence, suggesting the need for stringent clinical validation of smartphone apps in future. To the best of our knowledge, this work is the first to systematically identify and evaluate smartphone apps within the context of tinnitus.

Neurofeedback is a noninvasive neuromodulation technique employing real-time display of brain activity in terms of electroencephalography (EEG) signals to teach self-regulation of distinct patterns of brain activity or influence brain activity in a targeted manner. The benefit of this approach for control of symptoms in attention deficit disorders, hyperactivity, depression, and migraine has been proven. Studies in recent years have also repeatedly shown this treatment to improve tinnitus symptoms, although it has not become established as routine therapy. The primary focus of this review is the rational of EEG neurofeedback for tinnitus treatment and the currently available data from published studies. Furthermore, alternative neurofeedback protocols using real-time functional magnetic resonance imaging (fMRI) measurements for tinnitus control are considered. Finally, this article highlights how modern EEG analysis (source localization, connectivity) and the improving understanding of tinnitus pathology can contribute to development of more focused neurofeedback protocols for more sustainable control of tinnitus.

Recent research has used source estimation approaches to identify spatially distinct neural configurations in individuals with chronic, subjective tinnitus (TI). The results of these studies are often heterogeneous, a fact which may be partly explained by an inherent heterogeneity in the TI population and partly by the applied EEG data analysis procedure and EEG hardware. Hence this study was performed to re-enact a formerly published study (Joos et al., 2012) to better understand the reason for differences and overlap between studies from different labs. We re-investigated the relationship between neural oscillations and behavioral measurements of affective states in TI, namely depression and tinnitus-related distress by recruiting 45 TI who underwent resting-state EEG. Comprehensive psychopathological (depression and tinnitus-related distress scores) and psychometric data (including other tinnitus characteristics) were gathered. A principal component analysis (PCA) was performed to unveil independent factors that predict distinct aspects of tinnitus-related pathology. Furthermore, we correlated EEG power changes in the standard frequency bands with the behavioral scores for both the whole-brain level and, as a post hoc approach, for selected regions of interest (ROI) based on sLORETA. Behavioral data revealed significant relationships between measurements of depression and tinnitus-related distress. Notably, no significant results were observed for the depressive scores and modulations of the EEG signal. However, akin to the former study we evidenced a significant relationship between a power increase in the β-bands and tinnitus-related distress. In conclusion, it has emerged that depression and tinnitus-related distress, even though they are assumed not to be completely independent, manifest in distinct neural configurations.

mHealth technologies are increasingly utilized in various medical contexts. Mobile crowdsensing is such a technology, which is often used for data collection scenarios related to questions on chronic disorders. One prominent reason for the latter setting is based on the fact that powerful Ecological Momentary Assessments (EMA) can be performed. Notably, when mobile crowdsensing solutions are used to integrate EMA measurements, many new challenges arise. For example, the measurements must be provided in the same way on different mobile operating systems. However, the newly given possibilities can surpass the challenges. For example, if different mobile operating systems must be technically provided, one direction could be to investigate whether users of different mobile operating systems pose a different behaviour when performing EMA measurements. In a previous work, we investigated differences between iOS and Android users from the TrackYourTinnitus mHealth crowdsensing platform, which has the goal to reveal insights on the daily fluctuations of tinnitus patients. In this work, we investigated differences between iOS and Android users from the TrackYourHearing mHealth crowdsensing platform, which aims at insights on the daily fluctuations of patients with hearing loss. We analyzed 3767 EMA measurements based on a daily applied questionnaire of 84 patients. Statistical analyses have been conducted to see whether these 84 patients differ with respect to the used mobile operating system and their given answers to the EMA measurements. We present the obtained results and compare them to the previous mentioned study. Our insights show the differences in the two studies and that the overall results are worth being investigated in a more in-depth manner. Particularly, it must be investigated whether the used mobile operating system constitutes a confounder when gathering EMA-based data through a crowdsensing platform.