Clinical Research Directory

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.

Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients

Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Patients use a validated smartwatch and a validated sleep diary to collect data including mood score, sleep score, sleep duration, and adverse effects. Patients complete the diary for 20-25 days. Pain and mood are measured using numeric rating scales. Sleep score is measured using the Likert sleep scale. Within-patient differences are analyzed. Any change in pain, mood, or sleep scores by 2-points is considered significant.

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.

The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial

Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.

Residual Inhibition of 40 Hz Burst Sound in Tinnitus Patients

Tinnitus affects 10-15% of adults and is frequently associated with impaired quality of life, anxiety, and sleep disturbance. Conventional sound therapies based on continuous masking provide inconsistent and short-lived relief, and the neural mechanisms underlying residual inhibition (RI) remain unclear. This study aims to determine whether 40 Hz burst stimulation with high-frequency carriers can achieve longer-lasting RI than continuous sound, and to explore its underlying neural mechanisms using EEG.

Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus

Background and study aims Hearing problems are becoming more common. In the UK around 18 million adults have hearing loss or hear ringing or buzzing in their ears, which is called tinnitus. Many people wait a long time to be seen, partly because there are not enough audiologists - the specialists who test hearing and treat hearing problems. The standard hearing test is called pure-tone audiometry. An audiologist plays quiet sounds at different pitches through headphones and the person presses a button each time they hear one. The test is accurate, but it takes 20 to 30 minutes to complete, and needs a trained audiologist for all of that time. For people with tinnitus and comorbidity it can be especially tiring and slow. The research team has built a version of this test that uses artificial intelligence, called AI-PTA. Instead of following a fixed pattern, it chooses each sound based on the responses already given, which should mean fewer sound presentations are needed to find the same result. The audiologist stays with the person throughout and remains in charge of the test. This study asks three questions. 1. Does AI-PTA give the same hearing results as the standard test? 2. Is it quicker? 3. And do patients and staff find it acceptable? Who can participate? Adults aged 18 or over who have been diagnosed with sensorineural hearing loss, either with or without tinnitus, and who are due to attend the Royal National ENT \& Eastman Dental Hospital in London. Participants need enough English to read and complete questionnaires and to be able to give informed consent. People who have or report hyperacusis (an unusual sensitivity to everyday sounds), an active ear infection, or recent ear surgery cannot take part. What does the study involve? People who are interested are sent information about two weeks before a hospital appointment they already have. Those who decide to take part come in about 30 minutes early, meet a research audiologist, discuss the study, and if happy to take part, sign a consent form. They fill in a short questionnaire about their hearing health. They then have two hearing tests at that visit: the standard test, which is part of their normal care, and the AI-PTA test. Half of the participants have the standard test first and half have AI-PTA first, so that the order does not affect the results. They come back within a week for a shorter appointment, about 40 minutes, to repeat the AI-PTA test. This shows whether it gives the same response twice. They also fill in a questionnaire about what they think of using artificial intelligence in healthcare. That is the end of taking part, though participants are also invited to join an optional group discussion about their opinions on AI in healthcare later on. What are the possible benefits and risks of participating? There is no direct benefit to taking part. The results will help decide whether tests like this can shorten waiting times for hearing assessments in the NHS. The risks are small. Both tests use the same clinical equipment at the same safe sound levels that ordinary hearing tests use, and a qualified clinical audiologist is present throughout and can stop at any point. The main cost to participants is time: about 45 minutes extra at the first appointment and a second visit of about 40 minutes. Some people find hearing tests tiring, and people with tinnitus sometimes notice their tinnitus more during or after a hearing test. Taking part is voluntary, and choosing not to take part, or stopping at any time, will not affect anyone's care. Where is the study run from? Royal National ENT and Eastman Dental Hospitals in London which is part of University College London Hospitals NHS Foundation Trust, and University College London. When is the study starting and how long is it expected to run for? The study was approved in August 2026 and the first participant took part in September 2026. It is expected to run for 12 months, finishing in August 2027. Who is funding the study? The British Society of Otology (part of ENT UK), and the National Institute for Health and Care Research University College London Hospitals Biomedical Research Centre. Who is the main contact? Dr Roulla Katiri, uclh.ahead@nhs.net

Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus

The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.

Multidimensional Phenotyping of Patients With Tinnitus Using Electronic Health Records and a Specialty Database

This retrospective observational study will use historical electronic health record and tinnitus specialty database data from adult patients with tinnitus seen at the Eye and ENT Hospital of Fudan University between January 2015 and August 2026. The study will identify multidimensional tinnitus phenotypes, examine relationships between subjective tinnitus severity and objective audiometric measures, explore within-phenotype heterogeneity, and assess longitudinal phenotype stability and outcome patterns using existing follow-up records. No intervention or additional examination will be performed.

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.

Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

Study of the efficacy of different H-coils in chronic tinnitus. Hypothesis: Active Deep repetitive transcranial magnetic stimulation deeprTMS reduces tinnitus distress more effectively than placebo stimulation. Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.

Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus

This study tests whether a single dose of nicotine gum changes brain responses to sounds and the ability to detect target sounds in non-smoking adults with chronic tinnitus. In a double-blind, placebo-controlled, within-subject crossover design, each participant attends two sessions and receives a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. After gum administration, EEG is recorded at rest and during an active auditory oddball task. The primary measures are the P3 brain response (amplitude and latency) and oddball task accuracy and reaction time.

Acute Nicotine Gum and Tinnitus Loudness in Non-Smoking Adults

This study tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus. Nicotine acts on brain nicotinic acetylcholine receptors that regulate the balance of excitation and inhibition in auditory and attention networks, and may temporarily quiet the phantom sound while improving the ability to focus on relevant sounds. Using a double-blind, placebo-controlled, within-subject crossover design, each participant attended two sessions and received a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. The primary measure was the within-session change in a psychoacoustic match of tinnitus loudness; auditory selective attention was a secondary measure.

The CATT Trial: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment

The twofold aim of this single-blind two-arm 1:1 randomised control trial is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.

Treatment for PTSD and Tinnitus

In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.

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.

Treatment of Tinnitus With Olanzapine

This research aims to evaluate the effects of the drug olanzapine on the discomfort caused by tinnitus according to each patient's personality traits. Olanzapine is a drug used as an antipsychotic whose mechanism of action makes it potentially useful for the treatment of tinnitus.

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.

Emerging Indications for Hyperbaric Oxygen Treatment

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.

CBT, Breathing Exercises, and Psychoeducation on Tinnitus-Related Distress

Tinnitus is the perception of sound, such as ringing or buzzing, without any external source. It is common and can cause significant distress, including anxiety, depression, sleep problems, and reduced quality of life. Because there is currently no cure for tinnitus, treatment focuses on lowering the distress it causes and helping people cope. This study compared three different non-drug approaches to managing tinnitus-related distress: Cognitive behavioral therapy (CBT), a structured psychological treatment that helps people change unhelpful thoughts and reactions related to their tinnitus A breathing exercise (the 4-7-8 technique), a relaxation method intended to reduce stress Psychoeducation, which provides information to help people better understand their tinnitus Seventy adults with subjective tinnitus, aged 18 to 65, were randomly assigned to one of these three groups. Participants in each group received their assigned approach over a period of several weeks. The main goal was to see how much each approach reduced the impact of tinnitus on daily life, measured with a standard questionnaire called the Tinnitus Handicap Inventory. The study also looked at changes in anxiety and depression. Participants were assessed before treatment, after treatment, and again at 1 month and 6 months. The purpose of this study was to better understand which of these approaches may be most helpful for reducing tinnitus-related distress.

Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress

The broad goals of this project are to apply and validate the therapeutic utility of neurofeedback-guided intervention for tinnitus and its associated psychological sufferings. In this project, the investigators will evaluate whether targeted (non-auditory networks) neurofeedback-based training can restore emotional and cognitive health for individuals with bothersome tinnitus. The investigators will also link individual tinnitus scores with objective brain imaging measures before, during, and after the intervention. The investigators will accomplish these goals by using a combined brain imaging and behavioral experimental framework.

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.

A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)

This study will consist of two parts. Double blind Part A will assess the safety, tolerability, and pharmacokinetics of 7 days of dosing in healthy adults, while open label Part B will evaluate the safety, tolerability, and efficacy of a 2-week treatment course in adults with tinnitus.

Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia

This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.

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.