Assessing the Heterogeneity of Complaints Related to Tinnitus and Hyperacusis from an Unsupervised Machine Learning Approach: An Exploratory Study.

INTRODUCTION: Subjective tinnitus (ST) and hyperacusis (HA) are common auditory symptoms that may become incapacitating in a subgroup of patients who thereby seek medical advice. Both conditions can result from many different mechanisms, and as a consequence, patients may report a vast repertoire of associated symptoms and comorbidities that can reduce dramatically the quality of life and even lead to suicide attempts in the most severe cases. The present exploratory study is aimed at investigating patients' symptoms and complaints using an in-depth statistical analysis of patients' natural narratives in a real-life environment in which, thanks to the anonymization of contributions and the peer-to-peer interaction, it is supposed that the wording used is totally free of any self-limitation and self-censorship. METHODS: We applied a purely statistical, non-supervised machine learning approach to the analysis of patients' verbatim exchanged on an Internet forum. After automated data extraction, the dataset has been preprocessed in order to make it suitable for statistical analysis. We used a variant of the Latent Dirichlet Allocation (LDA) algorithm to reveal clusters of symptoms and complaints of HA patients (topics). The probability of distribution of words within a topic uniquely characterizes it. The convergence of the log-likelihood of the LDA-model has been reached after 2,000 iterations. Several statistical parameters have been tested for topic modeling and word relevance factor within each topic. RESULTS: Despite a rather small dataset, this exploratory study demonstrates that patients' free speeches available on the Internet constitute a valuable material for machine learning and statistical analysis aimed at categorizing ST/HA complaints. The LDA model with K = 15 topics seems to be the most relevant in terms of relative weights and correlations with the capability to individualizing subgroups of patients displaying specific characteristics. The study of the relevance factor may be useful to unveil weak but important signals that are present in patients' narratives. DISCUSSION/CONCLUSION: We claim that the LDA non-supervised approach would permit to gain knowledge on the patterns of ST- and HA-related complaints and on patients' centered domains of interest. The merits and limitations of the LDA algorithms are compared with other natural language processing methods and with more conventional methods of qualitative analysis of patients' output. Future directions and research topics emerging from this innovative algorithmic analysis are proposed.

Design and evaluation of tinnitus synthesis methods: from spectral to spatial matching.

PURPOSE: This study was designed to investigate methods to help patients suffering from unilateral tinnitus synthesizing an auditory replica of their tinnitus. MATERIALS AND METHODS: Two semi-automatic methods (A and B) derived from the auditory threshold of the patient and a method (C) combining a pure tone and a narrow band-pass noise centred on an adjustable frequency were devised and rated on their likeness over two test sessions. A third test evaluated the stability over time of the synthesized tinnitus replica built with method C, and its proneness to merge with the patient's tinnitus. Patients were then asked to try and control the lateralisation of this single percept through the adjustment of the tinnitus replica level. RESULTS: The first two tests showed that seven out of ten patients chose the tinnitus replica built with method C as their preferred one. The third test, performed on twelve patients, revealed pitch tuning was rather stable over a week interval. It showed that eight patients were able to consistently match the central frequency of the synthesized tinnitus (presented to the contralateral ear) to their own tinnitus, which leaded to a unique tinnitus percept. The lateralisation displacement was consistent across patients and revealed an average range of 29dB to obtain a full lateral shift from the ipsilateral to the contralateral side. CONCLUSIONS: Although spectrally simpler than the semi-automatic methods, method C could replicate patients' tinnitus, to some extent. When a unique percept between synthesized tinnitus and patients' tinnitus arose, lateralisation of this percept was achieved.

[Noise pollution: what are the health impacts?] / Pollution sonore : quels impacts sur la santé ?

NOISE POLLUTION: WHAT ARE THE HEALTH IMPACTS? Noise pollution resulting from human activities is more and more present and important. It can have deleterious consequences for hearing and health in general, but also for the quality of life. Its economic and societal cost is significant. Active strategies to reduce noise pollution are essential, particularly in urban areas, to prevent the risks of hearing and non-hearing disorders at the source.

POLLUTION SONORE: QUELS IMPACTS SUR LA SANTÉ ? La pollution sonore résultant des activités humaines est de plus en plus présente et importante. Elle peut engendrer des conséquences délétères tant pour l'audition que pour la santé en général, mais aussi pour la qualité de vie. Son coût économique et sociétal est significatif. Des stratégies actives de réduction de la pollution sonore sont indispensables, en particulier en milieu urbain, pour prévenir, à la source, les risques de troubles auditifs et extra-auditifs.

[Management of subjective tinnitus]. / Prise en charge des acouphènes subjectifs.

MANAGEMENT OF SUBJECTIVE TINNITUS. Subjective tinnitus, which is the perception of a sound in the absence of any actual external or internal acoustic stimulation, is a common symptom affecting about 15% of the population. It should be distinguished from objective tinnitus, which is the perception of a sound produced inside the human body (vascular pulsation or muscular contraction). In this article, we will only focus on the therapeutic management of subjective tinnitus, which is the most frequent case. Tinnitus may be a severe symptom that strongly impairs the patient's quality of life. Etiological treatments aimed at silencing tinnitus are rarely available. One should then consider alternative palliative interventions such as pharmacological treatments (off-market authorization), sound therapies, neuromodulation techniques or cognitive-behavioral psychotherapeutic interventions.

PRISE EN CHARGE DES ACOUPHÈNES SUBJECTIFS. L'acouphène subjectif, c'est-à-dire la perception d'un son en l'absence de toute stimulation sonore externe ou interne à l'organisme, est un symptôme fréquent qui affecte environ 15 % de la population générale. Il est à distinguer de l'acouphène dit objectif qui correspond à la perception d'un son produit à l'intérieur du corps humain (pulsation vasculaire ou contraction musculaire). Dans cet article, seule la prise en charge thérapeutique de l'acouphène subjectif, cas le plus fréquent, est abordée. L'acouphène peut parfois être un symptôme sévère altérant fortement la qualité de vie du patient. Disposant rarement de traitements étiologiques visant à éradiquer l'acouphène, des traitements palliatifs sont utilisés, tels que certains médicaments (hors AMM), les thérapies sonores, les techniques de neuromodulation ou les prises en charge psychothérapeutiques d'inspiration cognitivo- comportementale.

Comparing Clustering Methods Applied to Tinnitus within a Bootstrapped and Diagnostic-Driven Semi-Supervised Framework.

The understanding of tinnitus has always been elusive and is largely prevented by its intrinsic heterogeneity. To address this issue, scientific research has aimed at defining stable and easily identifiable subphenotypes of tinnitus. This would allow better disentangling the multiple underlying pathophysiological mechanisms of tinnitus. In this study, three-dimensionality reduction techniques and two clustering methods were benchmarked on a database of 2772 tinnitus patients in order to obtain a reliable segmentation of subphenotypes. In this database, tinnitus patients' endotypes (i.e., parts of a population with a condition with distinct underlying mechanisms) are reported when diagnosed by an ENT expert in tinnitus management. This partial labeling of the dataset enabled the design of an original semi-supervised framework. The objective was to perform a benchmark of different clustering methods to get as close as possible to the initial ENT expert endotypes. To do so, two metrics were used: a primary one, the quality of the separation of the endotypes already identified in the database, as well as a secondary one, the stability of the obtained clusterings. The relevance of the results was finally reviewed by two ENT experts in tinnitus management. A 20-cluster clustering was selected as the best-performing, the most-clinically relevant, and the most-stable through bootstrapping. This clustering used a T-SNE method as the dimensionality reduction technique and a k-means algorithm as the clustering method. The characteristics of this clustering are presented in this article.

REM Sleep Impairment May Underlie Sleep-Driven Modulations of Tinnitus in Sleep Intermittent Tinnitus Subjects: A Controlled Study.

(1) Background: Poor sleep and fragmented sleep are associated with several chronic conditions. Tinnitus is an auditory symptom that often negatively combines with poor sleep and has been associated with sleep impairment and sleep apnea. The relationship between tinnitus psychoacoustic characteristics and sleep is still poorly explored, notably for a particular subgroup of patients, for whom the perceived loudness of their tinnitus is highly modulated by sleep. (2) Methods: For this observational prospective study, 30 subjects with tinnitus were recruited, including 15 "sleep intermittent tinnitus" subjects, who had reported significant modulations of tinnitus loudness related to night sleep and naps, and a control group of 15 subjects displaying constant non-sleep-modulated tinnitus. The control group had matching age, gender, self-reported hearing loss grade and tinnitus impact on quality of life with the study group. All patients underwent a polysomnography (PSG) assessment for one complete night and then were asked to fill in a case report form, as well as a report of tinnitus loudness before and after the PSG. (3) Results: "Sleep Intermittent tinnitus" subjects had less Stage 3 sleep (p < 0.01), less Rapid-Eye Movement (REM) Sleep (p < 0.05) and more Stage 2 sleep (p < 0.05) in proportion and duration than subjects from the control group. In addition, in the "sleep Intermittent tinnitus" sample, a correlation was found between REM sleep duration and tinnitus overnight modulation (p < 0.05), as well as tinnitus impact on quality of life (p < 0.05). These correlations were not present in the control group. (4) Conclusions: This study suggests that among the tinnitus population, patients displaying sleep-modulated tinnitus have deteriorated sleep quality. Furthermore, REM sleep characteristics may play a role in overnight tinnitus modulation. Potential pathophysiological explanations accounting for this observation are hypothesized and discussed.

Online Discussions About Tinnitus: What Can We Learn From Natural Language Processing of Reddit Posts?

BACKGROUND: This study was aimed at identifying key topics in online discussions about tinnitus by examining a large data set extracted from Reddit social media using a natural language processing technique. METHOD: A corpus of 113,215 posts about tinnitus was extracted from Reddit's application programming interface. After cleaning the data for duplications and posts without any text information, the sample was reduced to 101,905 posts, which was subjected to cluster analysis using the open-source IRaMuTeQ software to identify main topics based on the co-occurrence of texts. These clusters were named by a panel of tinnitus experts (n = 9) by reading typical text segments within each cluster. RESULTS: The cluster analysis identified 16 unique clusters that belong to two topics, which were named "tinnitus causes and consequences" and "tinnitus management and coping." Based on their characteristics, the clusters were named: tinnitus timeline (10%), tinnitus perception (9.7%), medical triggers and modulators (8.8%), hearing research (8.8%), attention and silence (8.6%), social media posts about tinnitus (7.4%), hearing protection (7.3%), interaction with hearing health care providers (6.7%), mental health and coping (5.8%), music listening (5.7%), hope for a cure (5.6%), interactions with people without tinnitus (5.4%), dietary supplements and alternative therapies (3.2%), sleep (3.9%), dietary effects (1.7%), and writing about tinnitus and being thankful to online community (1.4%). CONCLUSIONS: Despite some limitations, tinnitus posts on Reddit provide rich real-world data to identify various issues and complaints that tinnitus patients and their significant others discuss in online communities. Some of the clusters identified here are novel (e.g., tinnitus timeline, interactions with people without tinnitus) and have not been much discussed in the tinnitus literature. The results suggest that individuals with tinnitus relay on social media for support and highlight the service delivery needs in providing social support through other means (e.g., support groups).

A portable neurofeedback device for treating chronic subjective tinnitus: Feasibility and results of a pilot study.

BACKGROUND: Several clinical studies have shown that neurofeedback (NFB) has the potential to significantly improve the quality of life of patients complaining of chronic subjective tinnitus. Yet the clinical applicability of such a therapeutic approach in the everyday practice has not been tested so far. OBJECTIVE: This study aims at investigating the feasibility and efficacy of a semi-automated NFB intervention by means of a portable device that eventually could be used by the patients at home on an everyday basis. The duration of setup procedures is minimized through the use of a dry electrodes electroencephalography (EEG) headset and an automated user-interface. METHODS: We conducted a pilot clinical study (non-controlled, single arm, NCT03773926). According to a predetermined power calculation, a homogeneous population of 33 subjects with strict inclusion criteria was enrolled. After inclusion, all patients underwent 10 NFB sessions lasting 50min each, over a period of 5 weeks and a 3-month follow-up period. According to previous studies, the NFB training aimed at increasing the alpha-band power (8-12Hz) in the EEG power spectrum on the averaged signal of leads FC1, FC2, F3 and F4. Tinnitus handicap inventory (THI) was used as a primary outcome measure. Secondary outcome measures were the visual analog scales (VAS) and the change of the alpha-band power within sessions and across training. Time points of assessment were before intervention (T1), after intervention (T2) and at the 3-month follow-up (T3). RESULTS: Patient exhibited a clinically significant decrease of the THI score, with a 23% decrease (N=28) on average between T1 and T2 and a 31% decrease (N=25) between T1 and T3. A significant increase of the alpha-band power within sessions was observed. No significant increase of the alpha-band power across sessions was observed. For the 19 subjects where sufficient data were exploitable, a significant correlation was found between the evolution of the alpha-band training across sessions and the evolution of the THI between T1 and T2. The sessions were well tolerated and no adverse effect was reported. CONCLUSION: This study suggests that neurofeedback has potential to suit everyday clinical practice with the goal to significantly reduce tinnitus intrusiveness. The merits and limitations of this NFB procedure are discussed, especially with respect to the choice of EEG electrodes to ensure a good signal quality.

Tinnitus and tinnitus disorder: Theoretical and operational definitions (an international multidisciplinary proposal).

As for hypertension, chronic pain, epilepsy and other disorders with particular symptoms, a commonly accepted and unambiguous definition provides a common ground for researchers and clinicians to study and treat the problem. The WHO's ICD11 definition only mentions tinnitus as a nonspecific symptom of a hearing disorder, but not as a clinical entity in its own right, and the American Psychiatric Association's DSM-V doesn't mention tinnitus at all. Here we propose that the tinnitus without and with associated suffering should be differentiated by distinct terms: "Tinnitus" for the former and "Tinnitus Disorder" for the latter. The proposed definition then becomes "Tinnitus is the conscious awareness of a tonal or composite noise for which there is no identifiable corresponding external acoustic source, which becomes Tinnitus Disorder "when associated with emotional distress, cognitive dysfunction, and/or autonomic arousal, leading to behavioural changes and functional disability.". In other words "Tinnitus" describes the auditory or sensory component, whereas "Tinnitus Disorder" reflects the auditory component and the associated suffering. Whereas acute tinnitus may be a symptom secondary to a trauma or disease, chronic tinnitus may be considered a primary disorder in its own right. If adopted, this will advance the recognition of tinnitus disorder as a primary health condition in its own right. The capacity to measure the incidence, prevalence, and impact will help in identification of human, financial, and educational needs required to address acute tinnitus as a symptom but chronic tinnitus as a disorder.

Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018).

A group of European experts reappraised the guidelines on the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) previously published in 2014 [Lefaucheur et al., Clin Neurophysiol 2014;125:2150-206]. These updated recommendations take into account all rTMS publications, including data prior to 2014, as well as currently reviewed literature until the end of 2018. Level A evidence (definite efficacy) was reached for: high-frequency (HF) rTMS of the primary motor cortex (M1) contralateral to the painful side for neuropathic pain; HF-rTMS of the left dorsolateral prefrontal cortex (DLPFC) using a figure-of-8 or a H1-coil for depression; low-frequency (LF) rTMS of contralesional M1 for hand motor recovery in the post-acute stage of stroke. Level B evidence (probable efficacy) was reached for: HF-rTMS of the left M1 or DLPFC for improving quality of life or pain, respectively, in fibromyalgia; HF-rTMS of bilateral M1 regions or the left DLPFC for improving motor impairment or depression, respectively, in Parkinson's disease; HF-rTMS of ipsilesional M1 for promoting motor recovery at the post-acute stage of stroke; intermittent theta burst stimulation targeted to the leg motor cortex for lower limb spasticity in multiple sclerosis; HF-rTMS of the right DLPFC in posttraumatic stress disorder; LF-rTMS of the right inferior frontal gyrus in chronic post-stroke non-fluent aphasia; LF-rTMS of the right DLPFC in depression; and bihemispheric stimulation of the DLPFC combining right-sided LF-rTMS (or continuous theta burst stimulation) and left-sided HF-rTMS (or intermittent theta burst stimulation) in depression. Level A/B evidence is not reached concerning efficacy of rTMS in any other condition. The current recommendations are based on the differences reached in therapeutic efficacy of real vs. sham rTMS protocols, replicated in a sufficient number of independent studies. This does not mean that the benefit produced by rTMS inevitably reaches a level of clinical relevance.

One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.

Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints ("outcome domains"). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT'ID recommendations are robust. The COMiT'ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.

Standardised profiling for tinnitus research: The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ).

BACKGROUND: The heterogeneity of tinnitus is substantial. Its numerous pathophysiological mechanisms and clinical manifestations have hampered fundamental and treatment research significantly. A decade ago, the Tinnitus Research Initiative introduced the Tinnitus Sample Case History Questionnaire, a case history instrument for standardised collection of information about the characteristics of the tinnitus patient. Since then, a number of studies have been published which characterise individuals and groups using data collected with this questionnaire. However, its use has been restricted to a clinical setting and to the evaluation of people with tinnitus only. In addition, it is limited in the ability to capture relevant comorbidities and evaluate their temporal relationship with tinnitus. METHOD: Here we present a new case history instrument which is comprehensive in scope and can be answered by people with and without tinnitus alike. This 'European School for Interdisciplinary Tinnitus Research Screening Questionnaire' (ESIT-SQ) was developed with specific attention to questions about potential risk factors for tinnitus (including demographics, lifestyle, general medical and otological histories), and tinnitus characteristics (including perceptual characteristics, modulating factors, and associations with co-existing conditions). It was first developed in English, then translated into Dutch, German, Italian, Polish, Spanish, and Swedish, thus having broad applicability and supporting international collaboration. CONCLUSIONS: With respect to better understanding tinnitus profiles, we anticipate the ESIT-SQ to be a starting point for comprehensive multi-variate analyses of tinnitus. Data collected with the ESIT-SQ can allow establishment of patterns that distinguish tinnitus from non-tinnitus, and definition of common sets of tinnitus characteristics which might be indicated by the presence of otological or comorbid systemic diseases for which tinnitus is a known symptom.

An Integrative Model Accounting for the Symptom Cluster Triggered After an Acoustic Shock.

Acoustic shocks and traumas sometimes result in a cluster of debilitating symptoms, including tinnitus, hyperacusis, ear fullness and tension, dizziness, and pain in and outside the ear. The mechanisms underlying this large variety of symptoms remain elusive. In this article, we elaborate on the hypothesis that the tensor tympani muscle (TTM), the trigeminal nerve (TGN), and the trigeminal cervical complex (TCC) play a central role in generating these symptoms. We argue that TTM overuse (due to the acoustic shock), TTM overload (due to muscle tension), and ultimately, TTM injury (due to hypoxia and "energy crisis") lead to inflammation, thereby activating the TGN, TCC, and cortex. The TCC is a crossroad structure integrating sensory inputs coming from the head-neck complex (including the middle ear) and projecting back to it. The multimodal integration of the TCC may then account for referred pain outside the ear when the middle ear is inflamed and activates the TGN. We believe that our model proposes a synthetic and explanatory framework to explain the phenomena occurring postacoustic shock and potentially also after other nonauditory causes. Indeed, due to the bidirectional properties of the TCC, musculoskeletal disorders in the region of the head-neck complex, including neck injury due to whiplash or temporomandibular disorders, may impact the middle ear, thereby leading to otic symptoms. This previously unavailable model type is experimentally testable and must be taken as a starting point for identifying the mechanisms responsible for this particular subtype of tinnitus and its associated symptoms.

A New Method for Assessing Masking and Residual Inhibition of Tinnitus.

Tinnitus masking and residual inhibition (RI) are two well-known psychoacoustic measures of tinnitus. While it has long been suggested that they may provide diagnostic and prognostic information, these measures are still rarely performed in clinics, as they are too time consuming. Given this issue, the main goal of the present study was to validate a new method for assessing these measures. An acoustic sequence made of pulsed stimuli, which included a fixed stimulus duration and interstimulus interval, was applied to 68 tinnitus patients at two testing sites. First, the minimum masking level (MML) was measured by raising the stimulus intensity until the tinnitus was unheard during the stimulus presentation. Second, the level of the stimulus was further increased until the tinnitus was suppressed during the silence interval between the acoustic pulses. This level was called the minimum residual inhibition level (MRIL). The sequential measurement of MML and MRIL from the same stimulus condition offers several advantages such as time efficiency and the ability to compare results between the MRIL and MML. Our study confirms that, from this new approach, MML and MRIL can be easily and quickly obtained from a wide variety of patients displaying either normal hearing or different hearing loss configurations. Indeed, MML was obtained in all patients except one (98.5%), and some level of MRIL was found on 59 patients (86.7%). More so, this approach allows the categorization of tinnitus patients into different subgroups based on the properties of their MRIL.

The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

A Case of Acoustic Shock with Post-trauma Trigeminal-Autonomic Activation.

This study reports the case of an acoustic shock injury (ASI), which did not result in a significant hearing loss, but was followed by manifold chronic symptoms both within (tinnitus, otalgia, tingling in the ear, tension in the ear, and red tympanum) and outside the ears (blocked nose, pain in the neck/temporal region). We suggest that these symptoms may result from a loop involving injury to middle ear muscles, peripheral inflammatory processes, activation and sensitization of the trigeminal nerve, the autonomic nervous system, and central feedbacks. The pathophysiology of this ASI is reminiscent of that observed in post-traumatic trigeminal-autonomic cephalalgia. This framework opens new and promising perspectives on the understanding and medical management of ASI.

Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus.

BACKGROUND: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is, therefore to, develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. METHODS: The 'Core Outcome Measures in Tinnitus: International Delphi' (COMIT'ID) study will use a mixed-methods approach that incorporates input from health care users at the pre-Delphi stage, a modified three-round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following Core Outcome Set publication. DISCUSSION: The COMIT'ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term. TRIAL REGISTRATION: This project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative.

[Tinnitus and cognitive-behavioral therapy: results after 1 year]. / Acouphènes et thérapie comportementale et cognitive. Résultats à un an.

INTRODUCTION: Tinnitus is a common auditory symptom that interferes with activities of daily living and is often associated with anxiety and depression. METHOD: This study included consecutive patients with chronic intense tinnitus for more than six months who were treated with Tinnitus Retraining Therapy (TRT), a cognitive-behavioral therapy, after previous treatment failed and after a clinical evaluation based on standardized questionnaires, including the Tinnitus Handicap Questionnaire (THQ). One year after the end of the TRT, the treatment was evaluated by the same standardized questionnaires. RESULTS: This prospective study included 96 consecutive patients (49 women, 47 men, mean age: 48 years). Tinnitus improved significantly in 75%, where significant improvement was defined as a final THQ score of less than 500 after CBT. This improvement varied according to initial THQ scores and was seen in: all patients with moderate (THQ<500), 70.3% of the patients with intermediate (5001001), and 34.8% of patients with severe (THQ>1000) tinnitus. CONCLUSION: CBT shows promise as a treatment of tinnitus-related distress.

[Magnetic stimulation of the auditory cortex for disabling tinnitus: preliminary results]. / Stimulation magnétique du cortex auditif dans les acouphènes invalidants: résultats préliminaries.

OBJECTIVE: Tinnitus - the perception of sound in one or both ears or in the head when no external sound is present - can be disabling and is especially difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique for activating or inactivating specific areas of the cortex. The aim of this study was to assess the feasibility of magnetic neurostimulation of the primary and secondary auditory cortex in the treatment of disabling chronic tinnitus. PATIENTS AND METHODS: Thirteen patients with tinnitus refractory to several conventional treatments underwent transcranial magnetic stimulation guided by functional magnetic resonance imaging (fMRI). We compared two types of stimulation of targets in the auditory cortex, identified by fMRI: 3-second pulses at high frequency (10 Hz) and 20-minute stimulations at a lower frequency (1 Hz). RESULTS: Brief high-frequency pulses of cortical magnetic stimulation (10 Hz) were not effective. On the other hand, prolonged low frequency (1 Hz) stimulation was effective in 62.5% of patients; the effect appeared 48 h after treatment and lasted for approximately 5 days. DISCUSSION: RTMS may be a new noninvasive technique for studying the cortical plasticity associated with the pathophysiologic mechanisms of chronic tinnitus and may lead to new treatment strategies for patients with disabling tinnitus resistant to all treatment.

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults.

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.