Recruiting

Mild Therapeutic Hypothermia Device for Chronic Tinnitus

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What is being tested

Cold pack-delivered mild therapeutic hypothermia

+ Sham (No Treatment)
Device
Who is being recruted

Tinnitus

+ Tinnitus, Subjective
From 18 to 55 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorRestorear Devices LLC
Study ContactKendall Stern, MPH
Last updated: September 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 16, 2025Actual 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.

Official TitleMild Therapeutic Hypothermia for Tinnitus Management 
Principal SponsorRestorear Devices LLC
Study ContactKendall Stern, MPH
Last updated: September 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
80 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Tinnitus
Tinnitus, Subjective
Criteria
4 inclusion criteria required to participate
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)
8 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Participants will wear a headband-style device for 30 minutes in a single session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Sham Arm. n=40
Group II
Sham
Participants will wear a headband-style control device for a single 30 minute session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Experimental Arm. n=40
Study Objectives
Primary Objectives

An adapted 4-question visual analog scale (VAS) will be used to assess tinnitus awareness, loudness, tolerance and disturbance before baseline treatment and repeated immediately after application using the online survey module. The VAS has been adapted to address the current, acute subjective experience of the participants' tinnitus rather than their general experience. The VAS consists of a sliding scale from 0 to 100, with 100 correlating to a greater disease burden/worse symptoms.
Secondary Objectives

The Patient Global Impression of Improvement (PGI-I) scale will be administered immediately post-treatment using the online survey module. This scale will allow participants to rank, subjectively, how their tinnitus compares after treatment versus to before. The PGI-I is a written rather than numerical scale, with potential values ranging from "very much better" to "very much worse".

A 6-item Device Acceptance Questionnaire (DAQ) will be used to assess the comfort and acceptability of the therapy (Aim 2). DAQ will be administered immediately after treatment in the experimental group. The DAQ consists of Likert scale questions pertaining to the comfort of the device, with responses including: "strongly disagree", "disagree", "agree", and "strongly agree".

A 2-question Adverse Event Questionnaire (AEQ) will be administered immediately post-treatment to record any mild adverse events associated with the therapy, including headache, dizziness, or irritation. Participants will identify adverse events they experienced from a provided list, with the option to add their own.

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
Recruiting
RestorEar DevicesBozeman, United StatesSee the location
Recruiting
One Study Center