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| ID | Type | Description | Link |
|---|---|---|---|
| GR014085 | Other Grant/Funding Number | Office of Naval Research |
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| Name | Class |
|---|---|
| Office of Naval Research (ONR) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Light | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in otoacoustic emissions (OAE) | Auditory performance will be measured through OAE testing | Baseline, up to 365 days |
| Change in central auditory performance (CAP) | Auditory performance will be measured through central auditory processing assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Hoffer, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Aeromedical Research Laboratory | Fort Rucker | Alabama | 36362 | United States | ||
| University of Miami Miller School of Medicine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2026 | Apr 15, 2026 | 11 |
| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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| Noise Stimulus | Other | 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. |
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| Sham Near Infrared Light | Device | 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. |
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| Baseline, up to 365 days |
| Miami |
| Florida |
| 33136 |
| United States |
| Wright-Patterson Air Force Base | Wright-Patterson Air Force Base | Ohio | 45433 | United States |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |