Noise Exposure and Near-Infrared Light

University of Miami

Status: Completed

Conditions: Hearing Loss, Noise-Induced

Treatments: Device: Sham Near Infrared Light; Other: Noise Stimulus; Device: Near Infrared Light

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03834714

20181214

GR014085 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Noise Stimulus and Infrared Light

Active Comparator group

Description:

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.

Treatment:

Other: Noise Stimulus

Device: Near Infrared Light

Noise Stimulus and Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Near Infrared Light

Other: Noise Stimulus