External Therapy for Tinnitus Management

Part of paid clinical trials in Bozeman, Montana.

Sponsor
Restorear Devices LLC
Study ID
NCT07017998
Status
Recruiting
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Conditions

  • Tinnitus
  • Tinnitus, Subjective

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Cold pack-delivered mild therapeutic hypothermia — DEVICE
    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) — DEVICE
    Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RestorEar DevicesBozemanMontana59715
Kendall Stern, MPH
[email protected]
(406) 414-6278
Suhrud Rajguru, PhD (PRINCIPAL_INVESTIGATOR)
Kendall Stern, MPH (PRINCIPAL_INVESTIGATOR)

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