Clinical Research Directory

Effect of Manual Acupuncture on Acute Primary Tinnitus: A Multicenter Randomized Controlled Clinical Trial

This multicenter clinical trial aims to investigate the efficacy and safety of manual acupuncture on acute primary tinnitus.

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

This study tests whether pairing non-invasive stimulation of the greater occipital nerve (NITESGON) with an attentionally demanding auditory frequency discrimination training task reduces tinnitus loudness and tinnitus-related distress. One hundred adults with chronic tonal tinnitus will be randomised to one of four groups in a 2×2 factorial design: real versus sham NITESGON and active versus passive listening during auditory stimulation. Participants complete eight sessions across four weeks, with outcomes assessed at baseline, end of treatment, 28 days post-treatment, and 6 months post-treatment.

The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults

This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).

The Effects of Conventional Therapy on Tinnitus, Disability, and Quality of Life in Patients With Tinnitus

A randomized, single-blind, controlled trial to evaluate the effects of neural therapy on tinnitus severity, disability, and quality of life in patients with tinnitus. The study is planned to be conducted between December 2025 and March 2026. The sample size is 30 patients. The number of centers is 1. The study duration is 3 months.

Apple Hearing Study

The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.

Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss

The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. Inner ear disorders can result from acoustic trauma, infections, inflammation, or other conditions that affect the cochlea, auditory nerve, or vestibular system. These conditions may lead to muffled hearing, ringing in the ears (tinnitus), balance disturbances, or reduced hearing sensitivity. The purpose of this study is to better understand how inner ear injuries develop and to evaluate potential treatments that may support hearing recovery or protect auditory function. Participants will undergo comprehensive ear and hearing evaluations including audiometry, speech recognition testing, tympanometry, and other diagnostic assessments used in audiology and otolaryngology. These tests help measure hearing thresholds, ear pressure, and auditory nerve responses. The study may also explore emerging regenerative medicine strategies aimed at restoring inner ear function. These approaches may include investigational therapies designed to promote repair of cochlear hair cells, reduce inflammation in the inner ear, or support neural recovery in the auditory pathway. Research may include evaluation of regenerative biological therapies, stem cell-based approaches, and other experimental technologies intended to support recovery of hearing or reduce symptoms such as tinnitus. Participants will be monitored over time to assess hearing outcomes, safety, and changes in auditory function. Study assessments may include repeat audiology tests, imaging studies, symptom questionnaires, and other clinical measurements used to track hearing health. The results of this research may contribute to improved diagnostic methods and potential future treatments for individuals with hearing loss or inner ear disorders.

CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship

The aim of this study is to investigate the relationship between Temporomandibular Disorders (TMD) and subjective tinnitus at both morphological and functional levels. Current literature suggests that somatosensory inputs from the temporomandibular joint (TMJ) and masticatory muscles can modulate auditory pathways, a phenomenon known as Somatosensory Tinnitus. However, the specific role of TMJ bone morphology and critical neighboring structures, such as the Petrotympanic Fissure (PTF), in this interaction remains unclear. In this clinical study, patients with tinnitus will undergo a comprehensive evaluation including Cone Beam Computed Tomography (CBCT) to quantitatively analyze condylar morphology and osteoarthritic changes. Additionally, audiological tests will be performed to assess the functional state of the auditory system. This multidisciplinary approach aims to clarify the biological link between TMD and tinnitus, potentially improving diagnostic protocols and highlighting the importance of TMJ stabilization in tinnitus management.

Navigated Repetitive TMS for Chronic Tinnitus

This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.

WHITBY: Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation studY

Tinnitus - the awareness of sound without any outside source - affects around 15% of people and can cause anxiety and depression. Treatment options are limited and do not address tinnitus directly (e.g., reduce its loudness). To do that, we must change brain activity causing tinnitus. Low-dose electrical stimulation, using a technique called transcranial Direct Current Stimulation (tDCS), is a promising approach. The technique is safe and easy to administer. Several small studies have tested tDCS for tinnitus showing some benefits. To assess whether these benefits will generalise to other patients, we need to conduct a randomised controlled trial - a large, rigorously controlled experiment based on prior agreed procedures. Clinical trials are expensive and time-consuming to run and thus require meticulous pilot work to establish the most effective treatment regimens and the most sensitive measures of treatment outcome. The current study aims to provide such pilot information for a clinical trial of tDCS treatment of tinnitus. Using a total of 40 patients, we will establish how to best to administer tDCS and measure resulting changes in tinnitus perception and associated brain activity. The current study is a crucial first step towards determining whether or not tDCS can effectively treat tinnitus.

Tinnitus and Treatment With umPEA-LUT

Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. However, all the previous causes have a common denominator, the presence of reactive oxygen species (ROS), in the cochlea which determines the damage and the consequent death of the hair cells into the ear. The sound (tinnitus) that the patient perceives is generated by the spontaneous movement of the cilia of the hair cells; this phenomenon arises when these cells begin to be damaged. Tinnitus can be also caused by a retrocochlear disorder such as damage of the auditory nerve (inflammatory and tumor cause). In case of an inflammatory origin, the factors released during inflammation can locally damage the nerves and spread into the cochlea destroying the hair cells. Tinnitus can also originate from damage in the central auditory pathway. In this case, the problem persistent. It is important to keep in mind that although initially the tinnitus may originate from a damage inside the cochlea, after 6 months of persistence chronicizes causing an activation (without stimulus) of the upper auditory areas. This zone of "hypersensitivity" is therefore responsible for chronic tinnitus. In addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric/psychological disorders, in those cases in whom there is an involvement of the hypothalamus, as showed by neuropsychological studies. Tinnitus can be temporary and disappear spontaneously or, in the most of cases, be persistent and extremely annoying/stressful for the patient. At night in particular, in the absence of noise, the patient suffers more the presence of this ghost sound, which in some occasions prevents sleep. Insomnia negatively impacts on tinnitus increasing its duration and intensity, thus establishing a perpetual cycle of stress into the brain. The latter phenomenon worses and chronicizes the symptom . Stress causes inflammation with ROS increase, which can affect both the peripheral and central auditory pathways. Recently, it has been shown that tinnitus can be a symptom of neuro-inflammatory pathologies such as, for example, Multiple Sclerosis. The effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone. Keeping on mind inflammation and neuro-inflammation and considering the exchange between cerebrospinal fluid and perilymph , we speculate that the use of a molecule capable of reducing inflammation and modulating the action of mast cells and microglia, could be an effective tool to resolve tinnitus; moreover, thanks to its powerful action at the level of neuro-inflammation, it could reduce the hyper-activity in the upper auditory tracts, thus reducing/abolishing noise. umPeaLut combines palmitoylethanolamide, which modulates the activity of mast cells, macrophages and microglia and luteolin, a bioflanoid extracted from fruits with anti-oxidant properties, able to improve microcirculation. Because the alterations of the ear microcirculation can be an additional cause of tinnitus, we believe that luteolin content can be an ulterior benefit. Although various attempts have been made to use a mono-molecule, recent studies have shown that combination of several elements could reduce tinnitus ; PeaLut, in its ultra-micronized form with high bioavailability, could be the perfect solution. This study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.

Noninvasive Therapy for Tinnitus

The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.

Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus

This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.

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.

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.

Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.

Management of Acute 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. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence 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, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.

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.

Assessment of Customized Bimodal Stimulation for Tinnitus

The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.

Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus

This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. The main questions we aim to answer are: * Determine if treatment of temporomandibular disorder with a stabilizing occlusal splint improves somatosensory tinnitus. * Identify which patient-related, tinnitus-related, and temporomandibular disorder-related factors contribute to the therapeutic effect.

External Therapy for Tinnitus Management

The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are: 1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change. 2. Ascertain the comfort and acceptability of the hypothermia device and therapy. Participants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving therapy to those from a control group.

Somatosensory Tinnitus RCT

The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus

The goal of this clinical trial is to assess the effectiveness of a sound-based passive treatment for reducing stress and annoyance induced by tinnitus, and how this therapy may improve tinnitus sufferers' quality of life. The main questions it aims to answer are: • \[question 1: to assess the efficacy of the LUCID/VIBE in managing the tinnitus handicap (measured by the reducing of the annoyance/stress response to tinnitus) contributing to the improvement of the quality of life of people living with tinnitus\] and • \[question 2: assess the efficacy of LUCID/VIBE in providing temporary relief through masking, such that it results in a reduction of the perceived loudness of tinnitus\]. Participants will \[use the VIBE app for 24 minutes a day for a period of 4 weeks. There will be two conditions, a Noise condition (the control condition in which the investigator will administer white noise) and the VIBE condition (the treatment condition). One approach involves broad-band masking with noise (Noise Condition), while the other uses music (LUCID Condition). Implementation of the noise condition will mirror the LUCID condition in terms of ease of access, look, feel, so that one condition does not look less professional than the other. Both conditions will be administered through the same app, and only the sound conditions will differ (white noise vs. LUCID music). All participants will be exposed to both the treatment and control conditions with the order of conditions counter-balanced (i.e., a cross-over design).

Efficacy of Donepezil in Patients With Chronic Tinnitus

This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.