Hearing Loss, Noise-InducedPhase 2PINIHL-AETNCT04774250
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
A Phase 2 study testing Zonisamide 100Mg Cap in people with Hearing Loss, Noise-Induced, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced
- What is being tested?
- Zonisamide 100Mg Cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 23 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
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.
Read the 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
- Being tested
- Zonisamide 100Mg Cap, Placebo
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide 100Mg CapDrug
Also called Zonegran, ZNS
ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
PlaceboDrug
Also called microcrystalline cellulose
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide | Experimental | For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO). Receives: Drug: Zonisamide 100Mg Cap |
| Placebo | Placebo comparator | For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days (+/- 3 days) after training
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline (before shooting) and 30 days (+/-3 days) after training
Electrocochleography (ECochG) Latency
To measure for changes in ECochG latency between baseline (before training) visit and 30-days after training visits.
Measured: baseline (before shooting) and 30 days (+/-3 days) after training
Electrocochleography (ECochG) Width
To measure for changes in ECochG width between baseline (before training) visit and 30-days after training visits.
Measured: baseline (before shooting) and 30 days (+/-3 days) after training
Determine PGx Link Between Noise Induced Hearing Loss (NIHL) and Zonisamide (ZNS)
Exploratory analysis to determine a pharmacogenetic link between noise induced hearing loss (NIHL) and zonisamide (ZNS) treatment effect.
Measured: Baseline prior to training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start10 Nov 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, Noise-InducedStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, and placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Texas, Gateway Biotechnology, Inc.
- Responsible party
- Sponsor
- Investigators
- Craig A Buchman, MD, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774250
- Sponsor's protocol ID
- PINIHL-AET_UA
- Acronym
- PINIHL-AET
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2021
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
- ClinicalTrials.gov ID
- NCT04774250
- Acronym / sponsor ID
- PINIHL-AET / PINIHL-AET_UA
- Conditions
- Hearing Loss, Noise-Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Texas, Gateway Biotechnology, Inc.
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, and placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Zonisamide | Experimental | Drug: Zonisamide 100Mg CapFor subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO). |
| Placebo | Placebo comparator | Drug: PlaceboFor the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide 100Mg CapAlso: Zonegran, ZNSZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. | Drug | Zonisamide |
| PlaceboAlso: microcrystalline celluloseThe placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. | Drug | Placebo |
Primary outcome
Proportion of Officers With Permanent Threshold Shift (PTS)
Time frame: 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.
7 secondary outcomes
Distortion Product Otoacoustic Emissions (DPOAE)
Time frame: baseline (before shooting), 30 days (+/-3 days) after training
Ultra-high Frequency Audiometry
Time frame: baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training
Electrocochleography (ECochG) AP Amplitude
Time frame: baseline (before shooting) and 30 days (+/-3 days) after training
Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold
Time frame: baseline (before shooting) and 30 days (+/-3 days) after training
Electrocochleography (ECochG) Latency
Time frame: baseline (before shooting) and 30 days (+/-3 days) after training
Electrocochleography (ECochG) Width
Time frame: baseline (before shooting) and 30 days (+/-3 days) after training
Determine PGx Link Between Noise Induced Hearing Loss (NIHL) and Zonisamide (ZNS)
Time frame: Baseline prior to training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Buchman, MD, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide 100Mg Cap in people with Hearing Loss, Noise-Induced, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Officers With Permanent Threshold Shift (PTS) (time frame: 30 days (+/- 3 days) after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.