RECRUITING

External Therapy for Tinnitus Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mild Therapeutic Hypothermia for Tinnitus Management

Quick Facts

Study Start:2025-07-01
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07017998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus;
  2. * Suffering from subjective tinnitus for at least 30 days;
  3. * Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12,
  4. * Tinnitus is constant in nature (defined as audible at least 75% of waking hours).
  1. * Very mild tinnitus (THI values \<12);
  2. * Tinnitus that is intermittent in nature;
  3. * Tinnitus described as non-auditory or pulsatile in nature;
  4. * 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;
  5. * Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.
  6. * 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;
  7. * 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.
  8. * Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.

Contacts and Locations

Study Contact

Kendall Stern, MPH
CONTACT
(406) 414-6278
kendall.stern@restorear.com
Suhrud Rajguru, PhD
CONTACT
(801) 641-8180
srajguru@restorear.com

Principal Investigator

Suhrud Rajguru, PhD
PRINCIPAL_INVESTIGATOR
RestorEar Devices
Kendall Stern, MPH
PRINCIPAL_INVESTIGATOR
RestorEar Devices

Study Locations (Sites)

RestorEar Devices
Bozeman, Montana, 59715
United States

Collaborators and Investigators

Sponsor: Restorear Devices LLC

  • Suhrud Rajguru, PhD, PRINCIPAL_INVESTIGATOR, RestorEar Devices
  • Kendall Stern, MPH, PRINCIPAL_INVESTIGATOR, RestorEar Devices

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Tinnitus
  • Tinnitus, Subjective