Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Noise Exposure and NIL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03834714
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Office of Naval Research (ONR)
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date August 7, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03834714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Noise Exposure and NIL
Official Title  ICMJE Noise Exposure and NIL on Auditory Health
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Hearing Loss, Noise-Induced
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Active treatment
  • 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
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael E Hoffer, MD 3052431484 michael.hoffer@maimi.edu
Contact: Constanza Hoffer 3052437102 cpelusso@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834714
Other Study ID Numbers  ICMJE 20181214
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Identified participant data will not be shared
Responsible Party Michael E. Hoffer, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Office of Naval Research (ONR)
Investigators  ICMJE
Principal Investigator: Michael E Hoffer, MD University of Miami
PRS Account University of Miami
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP