Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Gateway Biotechnology, Inc.; United States Department of Defense; University of Texas
• Treatments: Zonisamide

Criteria

Screening Inclusion Criteria:

• 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 Inclusion Criteria:

• 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 Criteria:

• 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:

1. 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.

2. ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.

3. WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.