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

Phase 2TerminatedNCT04774250

Washington University School of Medicine3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Hearing Loss, Noise-Induced

Interventions

Zonisamide 100Mg CapDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Akron

Akron, Ohio, United States

Outcomes

Primary Outcomes

Proportion of Officers With Permanent Threshold Shift (PTS)

The proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-shooting as compared to baseline audiogram.

Time frame: 30 days (+/- 3 days) after training

Secondary Outcomes

Distortion Product Otoacoustic Emissions (DPOAE)

DPOAE amplitudes are measured to determine threshold shifts. A change is noted in DPOAE amplitude at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap).

Time frame: baseline (before shooting), 30 days (+/-3 days) after training

Ultra-high Frequency Audiometry

Number of participants that experience a change in ultra-high frequencies greater than 5 dB; to measure for both temporary and permanent high frequency audiometric changes. A significant change is defined for any frequency that is greater than 5 dB HL from baseline thresholds.

Time frame: baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training

Electrocochleography (ECochG) AP Amplitude

To measure for changes in ECochG AP amplitude between baseline (before training) visit and 30-days after training visits.

Time frame: baseline (before shooting) and 30 days (+/-3 days) after training

Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold

The WIN test battery consists of 35 words that are presented in a background noise (speech babble) with varying degrees of signal-to-noise ratios (SNR) from 24 dB HL to 0 dB HL. The WIN score will be repeated three times in order to assess test-retest reliability. The total number of words correctly identified will be used to calculate a dB HL S/N threshold by the Spearman-Karber equation at the mean of 50% correct points. Reported information is the change in score between baseline testing and testing 30 days after training. This measure assesses the change in signal-to-noise ratio (SNR) threshold, reported in decibels SNR (dB SNR), at which a participant correctly identifies 50% of the words presented in background noise.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.