Noise-Induced Hearing Loss-Acute Exposure Treatment (PINIHL-AET)
Hearing Loss, Noise-Induced
About this trial
This is an interventional prevention trial for Hearing Loss, Noise-Induced
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo a skull-based surgery that requires at least 1-hour of surgical-drilling
- Air conduction thresholds in the non-operated ears are no worse than 25 decibel (dB) hearing loss (HL) from 0.5 to 3 kilohertz (kHz), no worse than 30dB HL at 4kHz, and no worse than 45dB HL at 6 and 8 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Active Comparator
Zonisamide Pre-op + Placebo Post-op
Placebo Pre-op + Placebo Post-op
Placebo Pre-op + Zonisamide Post-op
For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules.
For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules.
For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO).