Noise Exposure and Near-Infrared Light

Not Applicable

Completed

• Conditions: Hearing Loss, Noise-Induced
• Interventions: Device: Near Infrared Light; Other: Noise Stimulus; Device: Sham Near Infrared Light

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-08
• Study Start: 2020-02-18
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• Screening hearing test failure
• Pregnant females
• Adults unable to provide consent
• History of significant ear surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Noise Stimulus and Infrared Light	Near Infrared Light	All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.
Noise Stimulus and Infrared Light	Noise Stimulus	All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.
Noise Stimulus and Sham	Noise Stimulus	All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.
Noise Stimulus and Sham	Sham Near Infrared Light	All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.

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