NCT06729632View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

December 31, 2026

Conditions
Noise ExposureNoise-induced Hearing LossNoise; Adverse EffectMild Therapeutic HypothermiaCoolingOccupational ExposureOccupational HealthHidden Hearing Loss
Interventions
DEVICE

Cold pack-delivered mild therapeutic hypothermia

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

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
collaborator

University of Miami

OTHER

collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

lead

Restorear Devices LLC

INDUSTRY