Health TrialsbyHealthPanel

Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

ConditionsNoise ExposureNoise-induced Hearing LossNoise; Adverse EffectMild Therapeutic HypothermiaCoolingOccupational ExposureOccupational HealthHidden Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRestorear Devices LLC

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Fluency in English

Disqualifiers

Abnormal tympanometric findings

Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)

Significant history of noise exposure (Non-firefighters only)

Temporomandibular joint disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cold pack-delivered mild therapeutic hypothermia

    Device

    Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBoundRx.

Treatment groups

116 Participants
are divided into 4 treatment groups
Group A: Safety ArmExperimental treatment 1 intervention
Group B: Efficacy Arm 1 - TreatmentExperimental treatment 1 intervention
Group C: Efficacy Arm 2 - Non-TherapeuticNo intervention 0 interventions
Group D: Efficacy Arm 3 - ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pure Tone Audiometry

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.

Time frame
Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
2

Distortion Product Otoacoustic Emissions

Distortion Product Otoacoustic Emissions (DPOAE) will be performed in the Safety and Efficacy Arms immediately post-treatment. DPOAE 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.

Time frame
Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
3

Adverse Event Questionnaire

The 2 question Adverse Event Questionnaire (AEQ) will be administered in both the Safety and Efficacy Arms. It will collect data on any adverse event associated with use of the device.

Time frame
Immediately post-treatment; 3-hours and 24-hours post-treatment.

Secondary outcomes

1

Device Acceptance Questionnaire

11 question survey about subjective experience and acceptance of the treatment. Includes Likert Scale questions about comfort, likelihood of use of the device, etc.

Time frame
Safety Arm: Post-initial treatment and at the end of week 4 post-enrollment; Efficacy Arms: Post-initial treatment and at the end of 12 months
2

Weekly Use Surveys

Experimental Efficacy Arm and Non-Firefighter Control Arms for Efficacy Study will complete weekly, 3 question survey monitoring the use of the device at home. Firefighters will be asked how many shifts they had that week and how many times they used the device. Non-firefighters will be asked about their noise exposure and device use.

Time frame
Weekly, from enrollment to end of treatment at 52 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Restorear Devices LLC

Lead sponsor

University of Miami

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov
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