Clinical trial NCT04774250: Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
Official title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hearing Loss, Noise-Induced
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Texas
name: Gateway Biotechnology, Inc.
First posted: 2021-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, and placebo-controlled
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The primary outcome measure is the proportion of officers with permanent threshold shift (PTS)
timeFrame: 30 days (+/- 3 days) after training
Secondary outcomes:
measure: Distortion product otoacoustic emissions (DPOAE)
timeFrame: baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training
measure: Ultra-high frequency audiometry
timeFrame: baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training
measure: Electrocochleography (ECochG)
timeFrame: baseline (before shooting) and 30 days (+/-3 days) after training
measure: Words In Noise Test (WIN)
timeFrame: baseline (before shooting) and 30 days (+/-3 days) after training
measure: Determine a link between noise induced hearing loss (NIHL) and zonisamide (ZNS) treatment effect as assessed by pharmacogenetic testing
timeFrame: Baseline prior to training
Other outcomes:
Locations:
city: Akron
country: United States
facility: University of Akron
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Craig A Buchman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: