Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT04774250
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04774250
Study Brief:
Protocol Section:
NCT04774250