Recruiting

Mild Therapeutic Hypothermia

Sponsor:

Restorear Devices LLC

Code:

NCT07071480

Conditions

Tinnitus

Tinnitus, Subjective

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cold pack-delivered mild therapeutic hypothermia

Sham device

Study Details

Brief summary:

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.

Conditions

Tinnitus

Tinnitus, Subjective

Study ID

NCT07071480

Start date

Nov 24, 2025

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18 years or older at the time of signing the consent form
  • Fluency in English or Spanish
  • Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours
  • At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)

Exclusion Criteria:

  • Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7)
  • Tinnitus described as non-auditory or pulsatile in nature
  • Catastrophic tinnitus, score ≥78 on the THI
  • Tinnitus that is intermittent in nature
  • Abnormal tympanometric findings
  • Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies
  • Otologic pathologies (including, but not limited to): acoustic neuroma/ vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
  • Temporomandibular joint disorder
  • Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions.
  • Active hearing aid use
  • Dizziness at the time of signing the consent form or at the time of starting the study protocol treatment
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mild Therapeutic Hypothermia (MTH) Arm

Subjects will receive hypothermia treatment delivered with ReBound devices, applied in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. MTH Arm will complete both Aims 1 and 2. n=20.

sham comparator: Control Arm

Subjects will receive a sham wearable headband in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. Control Arm will complete both Aims 1 and 2. n=20.

Interventions

Cold pack-delivered mild therapeutic hypothermia

Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.

Sham device

Sham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.

Primary outcome measure

  • Visual Analog Scale (VAS) of Tinnitus Severity [ Time Frame: VAS will be given to participants in both Experimental and Sham Arms. For Aim 1, VAS will be administered at baseline, immediately after treatment, and at 24 hours post-treatment. For Aim 2, VAS will be administered monthly for 6 months post-baseline. ]
  • Tinnitus Functional Index Adapted (TFI-Adapted) [ Time Frame: TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment. ]

Central Contacts and Locations

Central contacts

Kristine Harris

305-243-4611keh129@med.miami.edu

Suhrud M Rajguru, PhD

801-641-8180srajguru@restorear.com

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Suhrud M Rajguru, PhD

801-641-8180srajguru@restorear.com

Principal Investigator:

Suhrud M Rajguru, PhD

More Information

Sponsor

Restorear Devices LLC

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • tinnitus
  • ringing
  • ringing in the ears
  • subjective tinnitus
  • constant tinnitus
  • treatment
  • symptom reduction
  • symptom management
  • tinnitus management
  • intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Restorear Devices LLC on 2026-07-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.