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Noise Exposure and Near-Infrared Light

Primary Purpose

Hearing Loss, Noise-Induced

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near Infrared Light
Noise Stimulus
Sham Near Infrared Light
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Noise-Induced focused on measuring Noise induced hearing loss, Near infrared energy, Hering test

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • U.S. Army Aeromedical Research Laboratory
  • University of Miami Miller School of Medicine
  • Wright-Patterson Air Force Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Noise Stimulus and Infrared Light

Noise Stimulus and Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in auditory threshold
Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz

Secondary Outcome Measures

Change in otoacoustic emissions (OAE)
Auditory performance will be measured through OAE testing
Change in central auditory performance (CAP)
Auditory performance will be measured through central auditory processing assessments

Full Information

First Posted
February 5, 2019
Last Updated
April 15, 2022
Sponsor
University of Miami
Collaborators
Office of Naval Research (ONR)
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1. Study Identification

Unique Protocol Identification Number
NCT03834714
Brief Title
Noise Exposure and Near-Infrared Light
Official Title
Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Office of Naval Research (ONR)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Noise-Induced
Keywords
Noise induced hearing loss, Near infrared energy, Hering test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noise Stimulus and Infrared Light
Arm Type
Active Comparator
Arm 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.
Arm Title
Noise Stimulus and Sham
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Near Infrared Light
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Noise Stimulus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Near Infrared Light
Intervention Description
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 Outcome Measure Information:
Title
Change in auditory threshold
Description
Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz
Time Frame
Baseline, up to 365 days
Secondary Outcome Measure Information:
Title
Change in otoacoustic emissions (OAE)
Description
Auditory performance will be measured through OAE testing
Time Frame
Baseline, up to 365 days
Title
Change in central auditory performance (CAP)
Description
Auditory performance will be measured through central auditory processing assessments
Time Frame
Baseline, up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Hoffer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Aeromedical Research Laboratory
City
Fort Rucker
State/Province
Alabama
ZIP/Postal Code
36362
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Wright-Patterson Air Force Base
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Noise Exposure and Near-Infrared Light

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