Hearing Loss, Noise-InducedNCT03834714
Noise Exposure and Near-Infrared Light
A study testing Near Infrared Light and Noise Stimulus in people with Hearing Loss, Noise-Induced, run by University of Miami at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced
- What is being tested?
- Near Infrared Light and Noise Stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2020to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Screening hearing test failure
- Pregnant females
- Adults unable to provide consent
- History of significant ear surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
U.S. Army Aeromedical Research Laboratory
Fort Rucker, Alabama, 36362
University of Miami Miller School of Medicine
Miami, Florida, 33136
Wright-Patterson Air Force Base
Wright-Patterson Air Force Base, Ohio, 45433
About this study
Official title: 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.
- Conditions
- Hearing Loss, Noise-Induced
- Being tested
- Near Infrared Light, Noise Stimulus, Sham Near Infrared Light
- Keywords
- Noise induced hearing loss, Near infrared energy, Hering test
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Near Infrared Light; Other: 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. Receives: Other: Noise Stimulus; Device: Sham Near Infrared Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in auditory threshold
Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz
Measured: Baseline, up to 365 days
Secondary outcomes (2)
Change in otoacoustic emissions (OAE)
Auditory performance will be measured through OAE testing
Measured: Baseline, up to 365 days
Change in central auditory performance (CAP)
Auditory performance will be measured through central auditory processing assessments
Measured: Baseline, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start18 Feb 2020
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Noise-InducedStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Naval Research (ONR)
- Responsible party
- Principal investigator, Michael E. Hoffer, University of Miami
- Investigators
- Michael E Hoffer, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834714
- Sponsor's protocol ID
- 20181214
- Other IDs
- GR014085
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance
- ClinicalTrials.gov ID
- NCT03834714
- Acronym / sponsor ID
- 20181214
- Conditions
- Hearing Loss, Noise-Induced
- Keywords
- Noise induced hearing loss, Near infrared energy, Hering test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Office of Naval Research (ONR)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noise Stimulus and Infrared Light | Active comparator | Device: Near Infrared Light, Other: Noise StimulusAll 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. |
| Noise Stimulus and Sham | Sham comparator | Other: Noise Stimulus, Device: Sham Near Infrared LightAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Screening hearing test failure
- Pregnant females
- Adults unable to provide consent
- History of significant ear surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared LightNIR 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. | Device | Noise Stimulus and Infrared Light |
| Noise StimulusNoise 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. | Other | Noise Stimulus and Infrared Light, Noise Stimulus and Sham |
| Sham Near Infrared LightSham 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. | Device | Noise Stimulus and Sham |
Primary outcome
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
2 secondary outcomes
Change in otoacoustic emissions (OAE)
Time frame: Baseline, up to 365 days
Change in central auditory performance (CAP)
Time frame: Baseline, up to 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Noise-Induced
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Not yet recruiting
Intervention for Hearing Health Among Native Americans
Noise-Induced Hearing Loss
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Noise Exposure, Noise-induced Hearing Loss
RecruitingPhase 1/2
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Central Auditory Processing Disorder, Hearing Impaired (Partially)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Hoffer, MD principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near Infrared Light and Noise Stimulus in people with Hearing Loss, Noise-Induced, run by University of Miami at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in auditory threshold (time frame: Baseline, up to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.