NCT03834714

Noise Exposure and Near-Infrared Light

Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hearing Loss, Noise-Induced

Interventions

Type	Name	Description
DEVICE	Near Infrared Light	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.
OTHER	Noise Stimulus	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.
DEVICE	Sham Near Infrared Light	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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2019-02-08
• Last updated: 2022-04-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study