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NCT06729632 · ClinicalTrials.gov registry record · NA
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
A NA study of Noise Exposure and Noise-induced Hearing Loss, sponsored by Restorear Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 116
- Enrollment target
- 1
- Study location
NCT06729632: Recruiting NA study of Noise Exposure and Noise-induced Hearing Loss, sponsored by Restorear Devices.
NCT06729632 is a NA study of Noise Exposure and Noise-induced Hearing Loss that is actively recruiting participants, run by Restorear Devices. The registered enrollment target is 116 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06729632, a NA study of Noise Exposure and Noise-induced Hearing Loss, is actively recruiting participants, sponsored by Restorear Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters. Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).
Primary Outcome
Pure Tone Audiometry (PTA) will be performed in the Safety and Efficacy arms immediately post-treatment. PTA will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
Conditions Studied
Interventions
- DEVICE Cold pack-delivered mild therapeutic hypothermia
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06729632 shows while recruiting
NCT06729632 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 8 conditions, with Noise Exposure appearing as the primary indexed condition, and to 1 intervention - of which Cold pack-delivered mild therapeutic hypothermia is the first listed.
NCT06729632 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06729632 about?
NCT06729632 is a clinical study titled "Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss". The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. ...
What is the current status of trial NCT06729632?
This trial is currently recruiting. It is a NA study. The enrollment target is 116 participants. The study started on 2024-12-19. Estimated completion is 2026-12-31.
What conditions does trial NCT06729632 study?
This clinical trial studies the following conditions: Noise Exposure, Noise-induced Hearing Loss, Occupational Health, Occupational Exposure, Noise; Adverse Effect.
What interventions are being tested in trial NCT06729632?
The interventions under investigation include: Cold pack-delivered mild therapeutic hypothermia (DEVICE).
Who is sponsoring clinical trial NCT06729632?
This trial is sponsored by Restorear Devices, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06729632 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
Similar trials for Noise Exposure
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 NCT06729632's enrollment target sits among peer trials
116 808th of 2000 higher than 1,191 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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