Noise Exposure and Near-Infrared Light

Hearing Loss, Noise-Induced Clinical Trial

Official title:

Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834714
• Other study ID #: 20181214
• Secondary ID: GR014085
• Status: Completed
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced

Intervention

Device:
• Near 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.

Other:
• Noise 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.

Device:
• Sham 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Office of Naval Research (ONR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in auditory threshold	Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz	Baseline, up to 365 days
Secondary	Change in otoacoustic emissions (OAE)	Auditory performance will be measured through OAE testing	Baseline, up to 365 days
Secondary	Change in central auditory performance (CAP)	Auditory performance will be measured through central auditory processing assessments	Baseline, up to 365 days