Hearing Loss, Noise-Induced
Conditions
Keywords
Noise induced hearing loss, Near infrared energy, Hering test
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.
Interventions
DEVICENear Infrared Light
NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
OTHERNoise Stimulus
Noise stimulus will be administered, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise per the AFI 48-127 Occupational Noise and Hearing Conservation Program.
DEVICESham Near Infrared Light
Sham NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
Sponsors
Office of Naval Research (ONR)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Screening hearing test failure * Pregnant females * Adults unable to provide consent * History of significant ear surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in otoacoustic emissions (OAE) | Baseline, up to 365 days | Auditory performance will be measured through OAE testing |
| Change in central auditory performance (CAP) | Baseline, up to 365 days | Auditory performance will be measured through central auditory processing assessments |
Countries
United States
Outcome results
None listed