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32 active trials for Tinnitus

Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus

the investigators have recently shown that patients with drug-resistant temporal lobe epilepsy who have undergone brain surgery targeting the medial temporal lobe structures were more likely to develop tinnitus postoperatively. This discovery of a vulnerability to tinnitus associated with medial temporal lobe surgery to eliminate drug-refractory epileptic seizures provides a new clinical model of tinnitus, targeting temporal lobe regions as generators or mediators of this hearing disorder. The objective of this project is to study the impact of tinnitus on the cognitive, emotional, psychoacoustic and cerebral functioning associated with this hearing disorder, and to clarify the pathophysiology of tinnitus by comparing different groups of individuals with tinnitus (surgical epileptic patients or non-surgical ORL patients) to matched tinnitus-free groups (surgical tinnitus-free cases and healthy controls volunteer).

Start: June 2021

Treatment of Tinnitus With Migraine Medications

Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. It is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.

Start: September 2019

Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus

Tinnitus, or ringing in the ears, is a very common problem that often accompanies hearing loss. It affects up to 1 in 10 adults, and about 30% of people who experience chronic tinnitus find it very distressing. In these patients, symptoms of depression and anxiety often accompany tinnitus and there are no approved treatments. Clinical trials are ongoing to test a glutamate NMDA receptor antagonist (called esketamine), which is injected into the inner ear. However, the preliminary results with this medication show that it only works for tinnitus that results from acute injury. It does not treat tinnitus resulting from progressive hearing loss. Research in humans and animals suggest that the neurotransmitters glutamate and GABA are important in the development and maintenance of tinnitus. This data shows that over-activation of the NMDA receptor and a decrease in GABA signaling in the brain play a crucial role. Previous studies show that ketamine, which an antagonist at the NMDA receptor, increases GABA levels in the brain in participants with depression. Thus, in this experiment, this study will test the effect of ketamine on tinnitus, since it blocks the NMDA glutamate receptor and increase GABA levels. Two groups of participants will be included in this study: those who experience distress (symptoms of anxiety or depression) with tinnitus and those who have tinnitus but do not experience distress. Each participant will receive both ketamine and placebo on different days. Magnetic Resonance Spectroscopy (MRS) scans will be

Start: September 2019

Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus

This proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their tinnitus. The Study will be placebo controlled with each participant using an effective device for half of the enrollment period and a placebo device for half of the enrollment period. The order of placebo and effective usage will be randomized, and the researchers will be blinded to which device a participant is using. Study participants will be instructed in an online telehealth conference on how to operate the OtoBand and how to wear the OtoBand. Participants will be enrolled for approximately 30 days from Informed Consent to Wrap-up call.

Start: March 2021

Transcranial Electrical and Acoustic Stimulation for Tinnitus

Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with sinusoidal current in a fixed frequency, and finally transcranial random noise stimulation (tRNS), which is a subform of tACS generating a random range of low and high frequency alternating currents. A pilot study conducted by Shekhawat and colleagues in 2015 tested the effects of simultaneous electrical and acoustic stimulation. Using tDCS and bilateral broadband noise simultaneously, they found that more tinnitus patients report an improvement in tinnitus perception in comparison to conditions only using tDCS or sham. Further similar approaches very published in recent years, namely a pilot study conducted by Teissmann et al in 2014; study protocols of Rabau et al. in 2015 and Shekhawat et al. in 2015; and an experimental study by Lee et al. in 2017. Results were indicative of a superior efficacy of combined electrical and acoustic approaches, while large-scale controlled studies have not been performed. The need for extension and replication of these approaches is therefore timely. The aim behind our proposed approach, similar to the bimodal approaches above, is to couple the effects of tRNS and acoustic stimulation (AS) for better temporary tinnitus suppression and possible reversal of maladaptive neuroplasticity related to tinnitus. We aim at targeting the (bilateral) auditory cortex with tRNS as in former studies and combine it with white noise (WN) stimulation. This specific combination is novel in its nature and is building on cortical excitability following tRNS.

Start: February 2021

Cochlear Promontory Stimulation for Treatment of Tinnitus

Tinnitus is the perception of sound when no external noise is present. The Center for Disease Control (CDC) estimates over 50 million - nearly 15% of the general public -experience some form of tinnitus. Roughly 20 million people struggle with burdensome chronic tinnitus, with 2 million experiencing extreme and debilitating symptoms. The 2014 Clinical Practice Guideline on tinnitus from the American Academy of Otolaryngology - Head and Neck Surgery summarized the existing state of tinnitus management by stating "A cure for primary tinnitus does not yet exist, and despite claims to the contrary, no method has been proven to provide long-term suppression of tinnitus." The purpose of this study is to look at the safety and efficacy of cochlear promontory stimulation in the short term relief of tinnitus. The secondary goal of the study is to determine the optimum region(s) of the cochlear promontory in planning for an implantable electrical device for long term tinnitus suppression.

Start: January 2018

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary suppression of the tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.

Start: April 2021

Investigating Disinhibitory Brain Mechanism in Tinnitus and Hearing Loss

Tinnitus, the perception of sound in the absence of an external acoustic stimulus. Tinnitus is often perceived inside the head rather than the ear and is a common condition with a prevalence estimated between 10 and 15% in adults. Between 1 and 3% of this population are having a significant impact on their quality of life. Despite its high prevalence, the underlying mechanisms of tinnitus still remain unclear. The majority of tinnitus cases associated with some degree of hearing loss, making hearing loss the biggest risk factor for tinnitus. Recently, it has been suggested that hearing deficits, such as speech-in-noise difficulty, can exist in the absence of any overt hearing loss within the audiometric range (0.125-8 kHz). This is referred to as "hidden hearing loss" and has been suggested to be associated with hearing loss at above-audiometric (> 8 kHz) frequencies. This project is aimed at studying the underlying mechanisms of tinnitus and the possible relation with overt or hidden hearing loss. Specifically, the investigators want to test the hypothesis that tinnitus is caused by maladaptive plasticity arising as a result of auditory input deprivation. This idea is supported by the finding that tinnitus may disappear when the hearing, and thus auditory input, recover. Disruptions at lower levels of the auditory pathway could lead to alterations in synaptic transmission and neurotransmitter release in more central regions of the auditory system (e.g., in the auditory cortex). This may create an imbalance between neuronal excitation and inhibition, and re-routing of auditory pathways, leading to abnormal neural excitability and connectivity. In this study, the investigators question whether auditory cortex disinhibition is specifically related to tinnitus, or is a consequence of hearing loss. To answer this question, the investigators propose to conduct a study that aims to investigate the inhibition mechanism by quantifying GABA concentration level, neural activity and functional connectivity strength of auditory cortex using non-invasive imaging techniques, namely Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI). The investigators expected to possibly provide a tinnitus biomarker, and this may help to direct future treatments.

Start: April 2021

Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus

Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very common problem for Veterans. Hearing aids that deliver low-level amplification are being used by audiologists to help people with tinnitus who also have normal hearing. However, there is a lack of research evidence showing that this practice is effective. Despite this fact, the practice clearly is spreading. Reports from audiologists in the field as well as research presentations refer to hearing aids being used in this way. Use of hearing aids has been shown to reduce distress from tinnitus for people with hearing loss. Additionally, the use of external sound to help reduce the impact of tinnitus has been shown to be effective. There is clearly a gap in the research regarding the use of hearing aids as a therapeutic method to manage tinnitus when hearing is considered normal. This study will obtain pilot data evaluating people with normal hearing and bothersome tinnitus to find out whether low-level amplification through hearing aids may provide benefit.

Start: February 2020

Internet-based Cognitive Behavioral Therapy for Tinnitus

Most tinnitus sufferers experiences significant anxiety or depression that worsens the subjective symptoms related to tinnitus. In this study, we intend to use internet-based cognitive behavioral therapy (CBT) in addition to sound therapy to provide psychotherapy to patients with tinnitus. Multiple research studies have found CBT to be effective in improving the subjective symptoms of tinnitus. The internet-based CBT course developed for this study is 8 weeks in duration and organized into eight 1-week modules; each module contains 2-4 separate lessons and homework assignments. Patients will be given unique usernames and passwords. In each weekly module, patients will review educational materials online, do exercises. and will be given feedback based on the results of the completed exercises. In addition, patients are given different meditation exercises each week for relaxation and coping with their tinnitus. These interactive materials enable patients to manage and control any negative feelings and thoughts that may be associated with tinnitus and help take their attention away from tinnitus. Tinnitus loudness and annoyance will be measured before and after the program. An internet-based course enables care providers to monitor patients' progress with the CBT course remotely, and allows patients to learn CBT at their own convenience and schedule.

Start: February 2018

Assessment Of The Effect Of Pelvic Floor Dysfunction Related Temporamandibular Joint Problems On Tinnitus

The pelvic floor serves as stability and support as it is the postural balance and core resource base for the pelvic organs. A dysfunction in the organs in this area can affect the pelvic floor muscles, the functioning of an organs in the muscles. Incontinence organ prolapse, pelvic pain and sexual problems may occur when the support or stability of the pelvic floor is impaired. Pelvic floor novelization is not always seen weakness. Sometimes excessive contractions and excessive activity in muscle tone can be seen. Stress and anxiety-related tension are the main causes of pelvic floor dysfunctions. Involuntary contractions and excessive muscle tone in the pelvic floor muscles cause chronic pelvic pain syndrome, constipation and dyssynergic defecation problems. Some of these patients have complaints of tightening teeth in the temporamandibular joint, grinding teeth at night, together with contractions in the pelvic floor. The aim of this study is to investigate the effect of pelvic floor improvement on tinnitus level as a result of dysfunctional condition in temporamandibular joint with treatment practices of pelvic floor patients with excessive muscle activity.

Start: March 2021

Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

Start: July 2019

Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus

Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus. Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.

Start: March 2021

Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method

Tinnitus and hyperacusis are two hearing disorders that can severely impact the patient and their quality of life, as they may induce sleeping disorders, concentration troubles, social life disturbances. Mayfair Developments has created and developed the innovating ØREBLUE® method in order to relieve, possibly completely, tinnitus and hyperacusis symptoms. The ØREBLUE® method relies on a medical device, CE marked, that consists of an auditory stimulation box associated with five softwares. This medical device diffuses thanks to a headphone a specific and personalized sound therapy treatment for the patient. This retrospective, observational study aims at collecting data about the ØREBLUE® method used in routine care and describing its efficacy on tinnitus and hyperacusis.

Start: March 2019

Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

This is a monocentric, randomized, controlled, open label phase IV superiority trial. After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin). The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.

Start: December 2020

Notched Noise Therapy for Suppression of Tinnitus

Tinnitus ("ringing in the ears") has long been a problem for Veterans. The problem continues to escalate due to high levels of noise in the military, and because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder. In spite of limited research support, sound-based (acoustic) therapies are most often used for tinnitus intervention, and increasing numbers of commercial devices are becoming available that offer various acoustic-stimulus protocols. The proposed study will provide evidence from a randomized controlled trial comparing effects of acoustic-stimulus methods that are purported to suppress tinnitus and/or reduce its functional effects. The study will focus on methods with the strongest scientific rationale, i.e., noise that is notched around the predominant tinnitus-frequency region. Special ear-level devices will deliver these acoustic-therapy protocols that are purported to modify tinnitus-related neural activity. The study will follow a study recently completed by the applicant that provides preliminary evidence supporting this method.

Start: June 2021

Acoustic and Electrical Stimulation for the Treatment of Tinnitus

Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus. It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus. In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition. Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.

Start: January 2017

A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition

This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive neuromodulation technique) with a sham stimulation. In the sham situation, patients will undergo an identical treatment but no stimulation will be applied, allowing to control for placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study will result in final recommendations for a standardised protocol for the use of HD-tDCS in tinnitus patients. When accurate, individualised, and effective therapy is available for the patient, the total cost (both economical and personal) will decrease significantly. The investigation's findings will be relevant for all caretakers dealing with tinnitus patients (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists, audiologists, etc.).

Start: January 2019

Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus

Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.

Start: January 2019

UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)

The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different types of interventions (hearing aids, sound therapy, structured counseling, cognitive behavioral therapy) either as a single treatment or a combination of two treatments. There are several aims of the study: compare 1) single vs. combined treatments, 2) single treatments vs. other treatments, 3) ear and brain based interventions, 4) analyzing data of the clinical trial in combination with other recorded data (genetic and proteomic data, audiology data) to develop in silico models of tinnitus and a decision support system with the aim to aid in treatment decisions. This randomized controlled trial is harmonized over five clinical centers in Europe with the aim to include 100 patients per center and is part of the UNITI-project (UNification of treatments and Interventions for TInnitus patients) funded by the European Union's Horizon 2020 programme (grant agreement number 848261).

Start: February 2021