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Noise Exposure and NIL

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ClinicalTrials.gov Identifier: NCT03834714
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Office of Naval Research (ONR)
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

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 NIR light can mitigate the effects of noise exposure. The ability of NIR light therapy to protect against the effects of noise will be determined by measuring the health of the auditory system using hearing threshold measurements and monitoring the stability of audiometric data pre and post noise exposure. In addition to audiometric testing, additional tests of auditory function may be performed including, otoacoustic emissions (OAEs), and tests of central auditory performance, to further evaluate the protective ability of NIR light therapy. The noise exposures will be within the defined DoD and United States Air Force (USAF) noise exposure criteria

Condition or disease Intervention/treatment Phase
Hearing Loss, Noise-Induced Other: Active treatment Other: Control Phase 1 Phase 2

Detailed Description:

Noise Exposure - Unprotected Ears:

Using AFI 48-127 Table 1, every subject will be exposed, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise. Ear-specific threshold measurements as well as OAEs will be collected before and after the noise exposure sessions to measure the auditory system's response to the noise. Based on the broadband noise used in the experiment, the maximum effect on human thresholds can be observed at 3000, 4000, and 6000 Hz. Subjects who do not reach audiometric threshold changes of 10 dB HL or greater at any test frequency measured approximately 2 minutes post a noise dose will not be qualified to participate in the experiment. This is to ensure all subjects have similar sensitivities to noise. Any subject who reached an audiometric threshold change greater than 20 dB HL 2 minutes post-noise will be removed from the study. A complete post-test audiogram with individual ear responses will be accomplished before the end of each session. If hearing thresholds are not within ±5 dB HL of the baseline after 60 minutes of testing, the subject will be told to have minimal noise exposure overnight and to return the next day for another hearing test. Sessions involving noise exposure will be separated by at least 72 hours.

Test of Auditory Function and Performance:

Auditory function measurements will be completed using standard audiological tests and procedures that include: otoscopy, tympanometry, air conduction threshold measurements (hearing test), and OAE measurements. All measurements will be performed only during subject qualification, with the exception of the hearing tests and OAE measurements which will continue to be collected before and after exposures to noise and NIR light. Measurements of auditory processing will be collected using established batteries that can evaluate processes such as: loudness scaling and matching, sound lateralization, auditory discrimination, temporal aspects, auditory performance with competing acoustic signals, and auditory performance with degraded signals. These types of batteries are administered under headphones or by loud speakers at comfortable listening levels, similar to average conversational level and require a behavioral response from the subject (typically, repeating or selecting what was heard, or answering a question about the signals). The presentation is recorded voice on a disc or MP3 file, which is presented through a diagnostic audiometer or tablet. These measurements will be collected pre, during, and post noise exposure.

NIR Light Exposure:

Only subjects in the experimental group will receive exposure to NIR light therapy. The control group will have a powered-down device placed in the ears for a duration of 180 seconds. NIR light-therapy exposures are administered to each ear individually, for a duration of 180 seconds per ear. The 180 second NIR light-therapy exposures occur in each of the 4 sessions. To allow for maximum effectiveness, NIR light exposures will be administered on a schedule that provides adequate, but not excessive, separation between sessions. Table 2 illustrates the schedule that will be utilized in this study to accommodate the necessary administration requirements.

Table 2. NIR Exposure Schedule Session Minimum and Maximum Time Allowed Between Exposures

  1. First exposure
  2. 3-7 days after session 1
  3. 18-24 days after session 2
  4. 18-24 days after session 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded placebo controlled
Masking: Single (Participant)
Masking Description: Unknown what affect is being given
Primary Purpose: Treatment
Official Title: Noise Exposure and NIL on Auditory Health
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Active Comparator: Active treatment
Using AFI 48-127 Table 1, every subject will be exposed, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise. Ear-specific threshold measurements as well as OAEs will be collected before and after the noise exposure sessions NIR light-therapy exposures are administered to each ear individually, for a duration of 180 seconds per ear. The 180 second NIR light-therapy exposures occur in each of the 4 sessions. To allow for maximum effectiveness, NIR light exposures will be administered on a schedule that provides adequate, but not excessive, separation between sessions.
Other: Active treatment
Only subjects in the experimental group will receive exposure to NIR light therapy. . NIR light-therapy exposures are administered to each ear individually, for a duration of 180 seconds per ear. The 180 second NIR light-therapy exposures occur in each of the 4 sessions. To allow for maximum effectiveness, NIR light exposures will be administered on a schedule that provides adequate, but not excessive, separation between sessions.
Other Name: Near Infrared

Placebo Comparator: Control
Using AFI 48-127 Table 1, every subject will be exposed, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise. Ear-specific threshold measurements as well as OAEs will be collected before and after the noise exposure sessions t.The control group will have a powered-down device placed in the ears for a duration of 180 seconds
Other: Control
The control group will have a powered-down device placed in the ears for a duration of 180 seconds. NIR light-therapy exposures are administered to each ear individually, for a duration of 180 seconds per ear. The 180 second NIR light-therapy exposures occur in each of the 4 sessions. To allow for maximum effectiveness, NIR light exposures will be administered on a schedule that provides adequate, but not excessive, separation between sessions.
Other Name: Placebo




Primary Outcome Measures :
  1. The study endpoint will the mean magnitude of auditory threshold changes (from pre-noise to after noise) in the active NIRL group as compared to the control group. [ Time Frame: 30 days ]
    Audiometric Outcomes


Secondary Outcome Measures :
  1. The study will also examine the mean changes of Otoacoustic Emissions (OAE) after noise exposure in the NIRL group as compared to the control group [ Time Frame: 30 days ]
    Audiometric Outcome



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years old, male or female
  • Pass hearing exam with a threshold of 15 dB hearing or less, for each ear, at 3000 Hz, 4000 Hz, and 6000 Hz
  • Frequencies from 250 Hz to 3 kHz, as well as 8 kHz, must have a threshold of 25 dB HL or less for each ear
  • Normal otoscopic exam, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834714


Contacts
Contact: Michael E Hoffer, MD 3052431484 michael.hoffer@maimi.edu
Contact: Constanza Hoffer 3052437102 cpelusso@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Office of Naval Research (ONR)
Investigators
Principal Investigator: Michael E Hoffer, MD University of Miami

Responsible Party: Michael E. Hoffer, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03834714     History of Changes
Other Study ID Numbers: 20181214
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Identified participant data will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael E. Hoffer, University of Miami:
Noise induced hearing loss
Near infrared energy
Hering test

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural