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NCT07071480 · ClinicalTrials.gov registry record · NA
Noninvasive Therapy for Tinnitus
A NA study of Tinnitus and Tinnitus, Subjective, sponsored by Restorear Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07071480: Recruiting NA study of Tinnitus and Tinnitus, Subjective, sponsored by Restorear Devices.
NCT07071480 is a NA study of Tinnitus and Tinnitus, Subjective that is actively recruiting participants, run by Restorear Devices. The registered enrollment target is 40 participants, below the 12,618-participant average among 24 other Tinnitus trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07071480, a NA study of Tinnitus and Tinnitus, Subjective, is actively recruiting participants, sponsored by Restorear Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
Primary Outcome
3-item instrument used to assess participant's subjective perception of tinnitus. Includes sliding scales used by participants to score their perceived disease severity. VAS will be used to assess perceived tinnitus severity before baseline treatment and repeated immediately after treatment. The VAS consists of a sliding scale from 0 to 10, with 10 correlating to a greater disease burden/worse symptoms.
Conditions Studied
Interventions
- DEVICE Cold pack-delivered mild therapeutic hypothermia
- DEVICE Sham device
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2027-05-31 |
| Phase | NA |
What NCT07071480 shows while recruiting
NCT07071480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 12,618-participant average among 24 other Tinnitus trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Tinnitus appearing as the primary indexed condition, and to 2 interventions - of which Cold pack-delivered mild therapeutic hypothermia is the first listed.
NCT07071480 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07071480 about?
NCT07071480 is a clinical study titled "Noninvasive Therapy for Tinnitus". The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to ad...
What is the current status of trial NCT07071480?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-11-24. Estimated completion is 2027-05-31.
What conditions does trial NCT07071480 study?
This clinical trial studies the following conditions: Tinnitus, Tinnitus, Subjective.
What interventions are being tested in trial NCT07071480?
The interventions under investigation include: Cold pack-delivered mild therapeutic hypothermia (DEVICE), Sham device (DEVICE).
Who is sponsoring clinical trial NCT07071480?
This trial is sponsored by Restorear Devices, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07071480 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07071480's enrollment target sits among peer trials
40 19th of 24 higher than 5 of 24 other Tinnitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinnitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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