Recruiting

MTH

Sponsor:

Restorear Devices LLC

Code:

NCT07017998

Conditions

Tinnitus

Tinnitus, Subjective

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Cold pack-delivered mild therapeutic hypothermia

Sham (No Treatment)

Study Details

Brief summary:

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.

Conditions

Tinnitus

Tinnitus, Subjective

Study ID

NCT07017998

Start date

Jul 16, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

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

sham comparator: Control Arm

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

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 (No Treatment)

Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.

Primary outcome measure

  • Subjective Tinnitus Severity [ Time Frame: Immediately prior to and immediately after treatment or sham treatment. ]

Central Contacts and Locations

Central contacts

Kendall Stern, MPH

2068187219kendall.stern@restorear.com

Suhrud Rajguru, PhD

(801) 641-8180srajguru@restorear.com

Locations

RestorEar Devices

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Kendall Stern, MPH

(406) 414-6278kendall.stern@restorear.com

Principal Investigator:

Suhrud Rajguru, PhD

More Information

Sponsor

Restorear Devices LLC

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • tinnitus
  • ringing in the ears
  • ringing ears
  • symptom management
  • cooling
  • red light therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Restorear Devices LLC on 2026-07-28.