Status:
TERMINATED
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
United States Department of Defense
University of Texas
Conditions:
Hearing Loss, Noise-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 certifi...
Eligibility Criteria
Inclusion
- Screening
- Police officers who are scheduled for firearm training and/or certification on the range.
- At least 18 years of age.
- Air conduction thresholds are to be no worse than 25 dB HL from 0.5 kHz to 3 kHz, no worse than 30 dB HL at 4 kHz, and no worse than 45 dB HL at 6 and 8 kHz prior to shooting range exposure.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
- Enrollment
- Observed audiometric TTS ≥ 10 dB HL at 2, 3, 4 and/or 6 kHz
- Observed air-bone gap \< 10 dB HL at .5, 1, 2 and 4 kHz, with normal tympanometry
Exclusion
- History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors.
- History of moderate-to-severe kidney or liver disease.
- Acute viral, bacterial, fungal or parasitic infection.
- History of seizures.
- Currently pregnant or breast-feeding.
- Any current or history of otologic disorder.
- History of ototoxic drug use.
- Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice.
- For secondary outcomes, exclusion criteria is as follows:
- DPOAE data will be used as a secondary outcome measure of TTS, and participants will be excluded if their DPOAE is absent at more than 3/7 frequencies. Criteria for a present response is any response that is \> 5 dB SPL above the noise floor and replicable within ±5 dB SPL.
- ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.
- WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04774250
Start Date
November 10 2021
End Date
December 23 2022
Last Update
September 12 2025
Active Locations (1)
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1
University of Akron
Akron, Ohio, United States, 44325-3001