TerminatedPhase 2

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

Stopped: Low accrual

United States3 participantsStarted 2021-11-10

Plain-language 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.

Age range18 Years

SexALL

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✕. 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.

Proportion of Officers With Permanent Threshold Shift (PTS)

Timeframe: 30 days (+/- 3 days) after training

NCT IDNCT04774250

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-23

Results submitted2023-12-04