Noise Exposure and Near-Infrared Light

April 15, 2022 updated by: Michael E. Hoffer, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Fort Rucker, Alabama, United States, 36362
        • U.S. Army Aeromedical Research Laboratory
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Ohio
      • Wright-Patterson Air Force Base, Ohio, United States, 45433
        • Wright-Patterson Air Force Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Noise Stimulus and 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.
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.
Sham Comparator: Noise Stimulus and Sham
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, up to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in otoacoustic emissions (OAE)
Time Frame: Baseline, up to 365 days
Auditory performance will be measured through OAE testing
Baseline, up to 365 days
Change in central auditory performance (CAP)
Time Frame: Baseline, up to 365 days
Auditory performance will be measured through central auditory processing assessments
Baseline, up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Office of Naval Research (ONR)

Investigators

  • Principal Investigator: Michael E Hoffer, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2020

Primary Completion (Actual)

December 23, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181214
  • GR014085 (Other Grant/Funding Number: Office of Naval Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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