Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Proportion of Officers With Permanent Threshold Shift (PTS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study will be "masked" or "blinded" in the sense that all the study participants and the study team members will be blinded to the assignment in the study groups. Only the pharmacist who will prepare the drug packets and will seal the envelopes, and the programmer not involved with the study who will produce the random treatment assignments and print the labels will know the order of treatments for any subject. An independent medical professional who is not part of the study team will complete the de-identification of the study drug, and a procedure and documentation log will be in place for quality assurance purposes. The ZNS and placebo capsules will look, taste, and smell the same.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •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.
- •ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.
- •WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.
研究组 & 干预措施
Zonisamide
For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).
干预措施: Zonisamide 100Mg Cap (Drug)
Placebo
For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Officers With Permanent Threshold Shift (PTS)
时间窗: 30 days (+/- 3 days) after training
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.
次要结局
- Distortion Product Otoacoustic Emissions (DPOAE)(baseline (before shooting), 30 days (+/-3 days) after training)
- Ultra-high Frequency Audiometry(baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training)
- Electrocochleography (ECochG) AP Amplitude(baseline (before shooting) and 30 days (+/-3 days) after training)
- Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold(baseline (before shooting) and 30 days (+/-3 days) after training)
- Electrocochleography (ECochG) Latency(baseline (before shooting) and 30 days (+/-3 days) after training)
- Electrocochleography (ECochG) Width(baseline (before shooting) and 30 days (+/-3 days) after training)
- Determine PGx Link Between Noise Induced Hearing Loss (NIHL) and Zonisamide (ZNS)(Baseline prior to training)