Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774250
Status:
TERMINATED
Last Update Posted:
2023-05-26
First Post:
2021-02-23
Brief Title:
Noise-Induced Hearing Loss-Acute Exposure Treatment UA
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINIHL-AET
Brief Summary:
The purpose of this study is to assess the safety and efficacy of zonisamide ZNS for the treatment of noise-induced hearing loss in adults
Detailed Description:
This is a randomized double-blind and placebo-controlled study is to test whether zonisamide ZNS can treat noise-induced hearing loss in police officers on the range following training and certifications sessions Participants who meet the eligibility requirements will be randomized to receive either ZNS 100 milligrams mg or placebo
Study participants will be recruited from the Akron Police Department Summit County Police Department and other local surrounding police departments Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements These are officers that would be recommended andor required to complete these trainingscertifications despite this investigation and this investigation will have no influence on audiologic recommendations
After being informed about the study expectations and potential risks all individuals providing written informed consent will undergo screening to determine eligibility for study entry
Study participants will be recruited from the Akron Police Department Summit County Police Department and other local surrounding police departments Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements These are officers that would be recommended andor required to complete these trainingscertifications despite this investigation and this investigation will have no influence on audiologic recommendations
After being informed about the study expectations and potential risks all individuals providing written informed consent will undergo screening to determine eligibility for study entry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None