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

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Hearing Loss, Noise-Induced

Treatments: Drug: Placebo; Drug: Zonisamide 100Mg Cap

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT04774250

PINIHL-AET_UA

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, and placebo-controlled study is to test whether zonisamide (ZNS) can treat noise-induced hearing loss in police officers on the range following training and certifications sessions. Participants who meet the eligibility requirements will be randomized to receive either ZNS 100 milligrams (mg) or placebo.

Study participants will be recruited from the Akron Police Department, Summit County Police Department, and other local surrounding police departments. Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements. These are officers that would be recommended and/or required to complete these trainings/certifications despite this investigation and this investigation will have no influence on audiologic recommendations.

After being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Zonisamide

Experimental group

Description:

For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).

Treatment:

Drug: Zonisamide 100Mg Cap

Placebo

Placebo Comparator group

Description:

For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.

Treatment:

Drug: Placebo