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Noise Stimulus and Infrared Light for Noise-Induced Hearing Loss
N/A
Waitlist Available
Led By Michael E Hoffer, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 365 days
Awards & highlights
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.
Eligible Conditions
- Noise-Induced Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 365 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in auditory threshold
Secondary study objectives
Change in central auditory performance (CAP)
Change in otoacoustic emissions (OAE)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Noise Stimulus and Infrared LightActive Control2 Interventions
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.
Group II: Noise Stimulus and ShamPlacebo Group2 Interventions
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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Who is running the clinical trial?
Office of Naval Research (ONR)FED
14 Previous Clinical Trials
641 Total Patients Enrolled
University of MiamiLead Sponsor
935 Previous Clinical Trials
422,203 Total Patients Enrolled
Michael E Hoffer, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
186 Total Patients Enrolled
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