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

NCT ID: NCT04774250

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-12-23

Brief 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.

Detailed 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.

Conditions

Hearing Loss, Noise-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Zonisamide

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

Group Type: EXPERIMENTAL

Zonisamide 100Mg Cap

Intervention Type: DRUG

ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Interventions

Zonisamide 100Mg Cap

ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.

Intervention Type: DRUG

Placebo

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Intervention Type: DRUG

Other Intervention Names

Zonegran; ZNS; microcrystalline cellulose

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

Gateway Biotechnology, Inc.

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig A Buchman, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

University of Akron

Akron, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PINIHL-AET_UA

Identifier Type: -

Identifier Source: org_study_id