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

NCT06729632 | Recruiting FDA Device

• 2 other identifiers: DC0187602R44DC018760-02A1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 1.To test the safety and best duration for use for a new hypothermia device.
2. 2.To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.

Conditions

Noise Exposure; Noise-induced Hearing Loss; Noise; Adverse Effect; Mild Therapeutic Hypothermia; Cooling; Occupational Exposure; Occupational Health; Hidden Hearing Loss

Keywords

hearing preservation; hearing loss; noise-induced hearing loss; noise exposure; mild therapeutic hypothermia; cooling; post-exposure; prevention

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

• 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.

  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.

• 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.

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

Secondary Outcomes (2)

• Device Acceptance Questionnaire

  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

• Weekly Use Surveys

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

Study Arms (4)

Safety Arm

EXPERIMENTAL

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.

Device: Cold pack-delivered mild therapeutic hypothermia

Efficacy Arm 1 - Treatment

EXPERIMENTAL

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.

Device: Cold pack-delivered mild therapeutic hypothermia

Efficacy Arm 2 - Non-Therapeutic

NO INTERVENTION

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 - Control

ACTIVE COMPARATOR

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.

Device: Cold pack-delivered mild therapeutic hypothermia

Interventions

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.

Efficacy Arm 1 - Treatment; Efficacy Arm 3 - Control; Safety Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Active hearing aid users
• Adults unable to consent

Sponsors & Collaborators

• Restorear Devices LLC: lead
• University of Miami: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

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MeSH Terms

Conditions

Hearing Loss, Noise-Induced; Hearing Loss, Hidden; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suhrud M Rajguru, PhD

  RestorEar Devices

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhrud M Rajguru, PhD

CONTACT

801-641-8180; srajguru@restorear.com

Curtis S King

CONTACT

406-414-6278; cking@restorear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Aim 1 studies will use a crossover study design. Aim 2 studies will use a parallel model.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)