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External Therapy for Tinnitus Management

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Jun 30, 2026 to Jun 30, 2027
    • Study completion date: Dec 1, 2026 to Dec 1, 2027
    v5
  3. Start date changed from estimate of Jul 1, 2025 to Jul 16, 2025v4
  4. Re-verified, no change to tracked fieldsv3
  5. Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 2 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07017998
Lead Sponsor Restorear Devices LLC
Conditions
(from sponsor)		 Tinnitus, Tinnitus, Subjective
Related terms Tinnitus
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov