Therapeutic Hypothermia for Noise-Induced Hearing Loss

N/A

Recruiting

Led By Suhrud M Rajguru, PhD

Research Sponsored by Restorear Devices LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the use of a cooling device to protect the hearing of firefighters after exposure to loud noises. The study will test the safety and effectiveness of the device, and compare the results to a control group who do not use the device."

Who is the study for?

This trial is for firefighters who have been exposed to loud noise during their shifts and are at risk for noise-induced hearing loss. Participants should be willing to wear a hypothermia therapy device after their shifts over a year. Specific eligibility details are not provided, but typically, participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

What is being tested?

The study is testing a non-invasive hypothermia device applied using a cold pack to see if it can protect against hearing loss after noise exposure. Firefighters will use the device after their shifts, and their hearing will be compared to those who didn't receive the therapy or received a sham (fake) therapy.

What are the potential side effects?

The trial description does not specify side effects, but mild therapeutic hypothermia may cause discomfort, a sensation of cold, or skin changes where the device is applied. The study aims to test the safety, so monitoring for any adverse effects will be a key part of the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Event Questionnaire

Distortion Product Otoacoustic Emissions

Pure Tone Audiometry

Secondary study objectives

Device Acceptance Questionnaire

Weekly Use Surveys

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Safety ArmExperimental Treatment1 Intervention

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.

Group II: Efficacy Arm 1 - TreatmentExperimental Treatment1 Intervention

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.

Group III: Efficacy Arm 2 - Non-TherapeuticActive Control1 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.

Group IV: Efficacy Arm 3 - ControlActive Control1 Intervention

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.

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