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External Therapy for Tinnitus Management

NCT07017998 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Sham (No Treatment)

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

Sponsors & Collaborators

  • Restorear Devices LLC

    lead INDUSTRY

Principal Investigators

  • Suhrud Rajguru, PhD · RestorEar Devices

  • Kendall Stern, MPH · RestorEar Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-06-30
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017998 on ClinicalTrials.gov