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Completed

NCT Number: NCT03834714

Noise Exposure and Near-Infrared Light

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.

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Key information

Conditions

Hearing Loss, Noise-Induced Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near Infrared Light

Device

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.

Noise Stimulus

Other

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.

Sham Near Infrared Light

Device

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.

Primary outcomes

  1. Change in auditory threshold

    Time frame: 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 outcomes

  1. Change in otoacoustic emissions (OAE)

    Time frame: Baseline, up to 365 days

    Auditory performance will be measured through OAE testing

  2. Change in central auditory performance (CAP)

    Time frame: Baseline, up to 365 days

    Auditory performance will be measured through central auditory processing assessments

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Office of Naval Research (ONR)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2019
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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