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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04768569
Eligibility Criteria:
Inclusion Criteria:
* Patients who are scheduled to undergo a skull-based surgery that requires at least 45 minutes of surgical-drilling
* At least 18 years of age
* Air conduction thresholds in the non-operated ears are to be no worse than 25 decibel (dB) hearing loss (HL) for pure tone average 0.5, 1, and 2 kilohertz (kHz) with no individual threshold greater than 30 dB HL, and no worse than 45dB HL at 4 kHz at screening.
* Observed air-bone gap \< 10 dB HL at 0.5, 1, 2, and 4 kHz, with normal tympanometry.
* Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.
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 ear disorder and/or central auditory dysfunction in the non-operated ear
* History of ototoxic drug use
* Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04768569
Study Brief:
Protocol Section:
NCT04768569