Mild Therapeutic Hypothermia Device for Chronic Tinnitus
Cold pack-delivered mild therapeutic hypothermia
+ Sham (No Treatment)
Ear Diseases+6
+ Hearing Disorders
+ Nervous System Diseases
Treatment Study
Summary
Study start date: July 16, 2025
Actual date on which the first participant was enrolled.Tinnitus is a condition where a person hears a ringing or buzzing sound without any external noise causing it. It is quite common and can severely impact daily life by affecting sleep, concentration, and mood. Currently, there are no cures for tinnitus, and treatments mainly focus on masking the symptoms or helping people cope with the emotional impact. This study is exploring a new approach using mild therapeutic hypothermia (MTH) to potentially reduce the severity of tinnitus symptoms. By using a headband-style device called ReBound, which cools the inner ear structures, the study aims to provide a non-invasive and easy-to-use solution for those suffering from chronic tinnitus. In this study, participants will use the ReBound device at home, where it will deliver mild cooling to the ear area for 30 minutes. The study will compare the effects of the actual cooling treatment to a placebo treatment, which uses a non-cooling device. Participants will complete questionnaires before and after the treatment to assess changes in their tinnitus symptoms. Additionally, they will answer questions about the comfort and ease of use of the device. Researchers will monitor for any potential side effects, such as skin irritation or dizziness. This study offers a novel approach to managing tinnitus, potentially providing relief for those who struggle with this condition daily.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus; * Suffering from subjective tinnitus for at least 30 days; * Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12, * Tinnitus is constant in nature (defined as audible at least 75% of waking hours). Exclusion Criteria: * Very mild tinnitus (THI values \<12); * Tinnitus that is intermittent in nature; * Tinnitus described as non-auditory or pulsatile in nature; * Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder; * Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome. * Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments; * Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety/depression. * Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location