NCT03834714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

February 5, 2019

Last Update Submit

April 15, 2022

Conditions

Hearing Loss, Noise-Induced

Keywords

Noise induced hearing lossNear infrared energyHering test

Outcome Measures

Primary Outcomes (1)

  • Change in auditory threshold

    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 Outcomes (2)

  • Change in otoacoustic emissions (OAE)

    Baseline, up to 365 days

  • Change in central auditory performance (CAP)

    Baseline, up to 365 days

Study Arms (2)

Noise Stimulus and Infrared Light

ACTIVE COMPARATOR

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 LightOther: Noise Stimulus

Noise Stimulus and Sham

SHAM COMPARATOR

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 StimulusDevice: Sham Near Infrared Light

Interventions

Near Infrared LightDEVICE

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 and Infrared Light
Noise StimulusOTHER

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.

Noise Stimulus and Infrared LightNoise Stimulus and Sham
Sham Near Infrared LightDEVICE

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.

Noise Stimulus and Sham

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

U.S. Army Aeromedical Research Laboratory

Fort Rucker, Alabama, 36362, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Wright-Patterson Air Force Base

Wright-Patterson Air Force Base, Ohio, 45433, United States

Location

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael E Hoffer, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 8, 2019

Study Start

February 18, 2020

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)