Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment

PINIHL-AET_UA

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.

2021-11-10

2022-12-23

2022-12-23

Terminated

Early phase I

38

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, and placebo-controlled', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The study will be "masked" or "blinded" in the sense that all the study participants and the study team members will be blinded to the assignment in the study groups. Only the pharmacist who will prepare the drug packets and will seal the envelopes, and the programmer not involved with the study who will produce the random treatment assignments and print the labels will know the order of treatments for any subject. An independent medical professional who is not part of the study team will complete the de-identification of the study drug, and a procedure and documentation log will be in place for quality assurance purposes. The ZNS and placebo capsules will look, taste, and smell the same.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

2023-05-26