RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-12-11
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06729632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18-55 years old at the time of signing the consent form
  2. * Fluency in English
  1. * Abnormal tympanometric findings
  2. * Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
  3. * Significant history of noise exposure (Non-firefighters only)
  4. * Temporomandibular joint disorder
  5. * Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
  6. * Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions
  7. * Active hearing aid users
  8. * Adults unable to consent

Contacts and Locations

Study Contact

Suhrud M Rajguru, PhD
CONTACT
801-641-8180
srajguru@restorear.com
Curtis S King
CONTACT
406-414-6278
cking@restorear.com

Principal Investigator

Suhrud M Rajguru, PhD
PRINCIPAL_INVESTIGATOR
RestorEar Devices

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Restorear Devices LLC

  • Suhrud M Rajguru, PhD, PRINCIPAL_INVESTIGATOR, RestorEar Devices

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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