Noise Exposure and Near-Infrared Light
- Conditions
- Hearing Loss, Noise-Induced
- Registration Number
- NCT03834714
- Lead Sponsor
- University of Miami
- Brief Summary
The primary objective of this work is to determine the effect noise has on the auditory system (both auditory health and performance) and also the degree to which the effect of pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise exposure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 18-45 years old, male or female
- Pass hearing exam with a threshold of 25 decibels (dB) hearing or less, for each ear, for all frequencies tested from 500 Hz to 8000 Hz
- Normal otoscopic exam, otoacoustic emissions (OAEs), and middle ear function as demonstrated by a normal tympanogram
- Completion of a hearing history questionnaire
- Screening hearing test failure
- Pregnant females
- Adults unable to provide consent
- History of significant ear surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in auditory threshold Baseline, up to 365 days Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz
- Secondary Outcome Measures
Name Time Method Change in central auditory performance (CAP) Baseline, up to 365 days Auditory performance will be measured through central auditory processing assessments
Change in otoacoustic emissions (OAE) Baseline, up to 365 days Auditory performance will be measured through OAE testing
Trial Locations
- Locations (3)
U.S. Army Aeromedical Research Laboratory
🇺🇸Fort Rucker, Alabama, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Wright-Patterson Air Force Base
🇺🇸Wright-Patterson Air Force Base, Ohio, United States
U.S. Army Aeromedical Research Laboratory🇺🇸Fort Rucker, Alabama, United States