Trial · NCT04774250
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
NCT04774250, Phase 2, Terminated, Washington University School of Medicine; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Noise-Induced Hearing Loss-Acute Exposure Treatment (UA). Trials, record NCT04774250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04774250
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
- NCT number
- NCT04774250
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Hearing Loss, Noise-Induced
- Interventions
- Zonisamide 100Mg Cap, Placebo
- First posted
- 2021-03-01
- Last updated
- 2026-02-13
- Results first posted
- 2025-09-12
- Limitations and caveats
- The study was prematurely terminated due to the low number of eligible subjects (3 subjects); therefore, statistical analyses were not performed.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Officers With Permanent Threshold Shift (PTS) | 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. |
| Secondary | Distortion Product Otoacoustic Emissions (DPOAE) | baseline (before shooting), 30 days (+/-3 days) after training | 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). |
| Secondary | Ultra-high Frequency Audiometry | baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training | 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. |
| Secondary | Electrocochleography (ECochG) AP Amplitude | baseline (before shooting) and 30 days (+/-3 days) after training | To measure for changes in ECochG AP amplitude between baseline (before training) visit and 30-days after training visits. |
| Secondary | Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold | baseline (before shooting) and 30 days (+/-3 days) after training | 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. |
| Secondary | Electrocochleography (ECochG) Latency | baseline (before shooting) and 30 days (+/-3 days) after training | To measure for changes in ECochG latency between baseline (before training) visit and 30-days after training visits. |
| Secondary | Electrocochleography (ECochG) Width | baseline (before shooting) and 30 days (+/-3 days) after training | To measure for changes in ECochG width between baseline (before training) visit and 30-days after training visits. |
| Secondary | Determine PGx Link Between Noise Induced Hearing Loss (NIHL) and Zonisamide (ZNS) | Baseline prior to training | Exploratory analysis to determine a pharmacogenetic link between noise induced hearing loss (NIHL) and zonisamide (ZNS) treatment effect. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Officers With Permanent Threshold Shift (PTS) | 30 days (+/- 3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distortion Product Otoacoustic Emissions (DPOAE) | baseline (before shooting), 30 days (+/-3 days) after training | Each participant's left and right ears were analyzed for threshold shifts at 30 days (+/- 3 days) after training. | ears | COUNT_OF_UNITS |
| SECONDARY | Ultra-high Frequency Audiometry | baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Electrocochleography (ECochG) AP Amplitude | baseline (before shooting) and 30 days (+/-3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | millivolts (mV) | MEAN |
| SECONDARY | Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold | baseline (before shooting) and 30 days (+/-3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | dB SNR | MEAN |
| SECONDARY | Electrocochleography (ECochG) Latency | baseline (before shooting) and 30 days (+/-3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | milliseconds (ms) | MEAN |
| SECONDARY | Electrocochleography (ECochG) Width | baseline (before shooting) and 30 days (+/-3 days) after training | The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported. | milliseconds (ms) | MEAN |
| SECONDARY | Determine PGx Link Between Noise Induced Hearing Loss (NIHL) and Zonisamide (ZNS) | Baseline prior to training | While samples were collected, the miRNA assay was not completed and will never be completed, as miRNA assays require a minimum of 3 samples from each group to be completed and produce results. As only 1 sample was obtained from the zonisamide group and 2 samples from the placebo group, the threshold was never reached. This threshold was not explicitly stated in the protocol, but it is a widely accepted standard among statisticians for ensuring interpretable results. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Officers With Permanent Threshold Shift (PTS) | Zonisamide | PTS-positive participants | 0 | Participants | |
| Proportion of Officers With Permanent Threshold Shift (PTS) | Placebo | PTS-positive participants | 1 | Participants | |
| Proportion of Officers With Permanent Threshold Shift (PTS) | Zonisamide | PTS-negative participants | 1 | Participants | |
| Proportion of Officers With Permanent Threshold Shift (PTS) | Placebo | PTS-negative participants | 1 | Participants | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Zonisamide | No Shift | 1 | ears | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Placebo | No Shift | 0 | ears | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Zonisamide | Shift | 1 | ears | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Placebo | Shift | 3 | ears | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Zonisamide | Excluded | 0 | ears | |
| Distortion Product Otoacoustic Emissions (DPOAE) | Placebo | Excluded | 1 | ears |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zonisamide | 1 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | Zonisamide | 1 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Zonisamide | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zonisamide | 0 | 1 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | Zonisamide | 0 | 1 |
| Total, other adverse events | Placebo | 0 | 2 |
| Total, serious adverse events | Zonisamide | 0 | 1 |
| Total, serious adverse events | Placebo | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zonisamide vs Placebo: deaths from any cause | Trial comparisons |
| Zonisamide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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