Taking people in United StatesNo phase

Cooling device to protect firefighters' hearing from noise damage

Tests a cooling device after noise exposure in firefighters, looking at hearing loss.

Key facts

Who runs it: Restorear Devices LLC
Where: Miami, United StatesSee the site
Trial code: NCT06729632
Registry title: Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Status: Recruiting
People taking part: 116 people, planned
Started: 19 Dec 2024
Expected to end: 30 Sept 2027
Type of study: Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Cold pack-delivered mild therapeutic hypothermia
Record updated: 23 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult firefighters and adults who are not firefighters. It tests a cooling device worn after noise exposure to protect hearing.

Age: 18 to 55 years old when signing the consent form
Sex: All sexes
Earlier treatment: People currently getting medical, drug or other treatment for tinnitus (ringing in the ears) or other ear conditions cannot join.

Main reasons for not taking part

Abnormal results on an eardrum test (tympanometry), or, for non-firefighters, abnormal hearing tests from 500-8,000 Hz
Non-firefighters with a significant history of noise exposure
Jaw joint problems (temporomandibular joint disorder)
Ear diseases such as acoustic neuroma, chronic ear disease, Meniere's disease, hearing loss that comes and goes, or ear damage from drugs
Active hearing aid use, not fluent in English, or not able to give consent

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

Adults aged 18-55 years old at the time of signing the consent form
Fluency in English

Who cannot take part

Significant history of noise exposure (Non-firefighters only)
Temporomandibular joint disorder
Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions
Abnormal tympanometric findings
Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
Active hearing aid users
Adults unable to consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 55 years old?

Where in United States

University of MiamiMiami, United StatesContact: Suhrud M Rajguru, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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).

The 4 groups in the trial

Safety ArmTreatment being tested
Non-firefighter control subjects will receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared between MTH-treatment and sham in each subject. n=24.
Treatment: Cold pack-delivered mild therapeutic hypothermia
Efficacy Arm 1 - TreatmentTreatment being tested
Firefighters will receive hypothermia treatment delivered with ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.
Treatment: Cold pack-delivered mild therapeutic hypothermia
Efficacy Arm 2 - Non-TherapeuticNo study treatment, for comparison
Firefighters will receive non-therapeutic "treatment" delivered with normothermic ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. n=24.
Efficacy Arm 3 - ControlExisting treatment, for comparison
Age- and sex-matched non-firefighter control group will receive MTH-treatment quarterly over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.
Treatment: Cold pack-delivered mild therapeutic hypothermia