Prevention of Noise-induced Hearing Loss
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ClinicalTrials.gov Identifier: NCT02049073 |
Recruitment Status :
Withdrawn
(new data makes this trial unethical)
First Posted : January 29, 2014
Last Update Posted : November 6, 2017
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Noise-induced hearing loss affects an estimated 5% of the worldwide population, with 30-40 million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may be occupational, blast noise, or recreational. Trauma to the inner ear can occur through transient hearing loss or permanent hearing loss. Although hearing recovers after temporary transient hearing loss, growing evidence suggests that repeated temporary transient hearing loss may lead to a permanent hearing loss. Currently, there are no treatments and there are no known medications that can be used clinically to prevent noise-induced hearing loss in humans.
The long-term goal of this research is to find medications that can prevent noise-induced hearing loss. The purpose of the present pilot study is to evaluate zonisamide and methylprednisolone as medications to prevent temporary transient hearing loss in humans.
Condition or disease | Intervention/treatment | Phase |
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Noise-induced Hearing Loss | Drug: Zonisamide Drug: Methylprednisolone | Phase 1 Phase 2 |
Noise-induced hearing loss (NIHL) affects an estimated 5% of the worldwide population, with 30-40 million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may be occupational (e.g., manufacturing, construction), blast noise (e.g., firearms or explosions), or recreational (e.g., loud music, power tools). Trauma to the inner ear can occur through transient hearing loss (temporary threshold shifts, TTS) or permanent hearing loss (permanent threshold shift, PTS). Although hearing recovers after a TTS in about 24-48 hours, growing evidence suggests that repeated TTS may lead to PTS. Both TTS and PTS lead to a decrease in hearing thresholds at 3000 to 6000 Hz.
Currently, there are no treatments for human NIHL although this is an area of active investigation. Protection against NIHL consists of limiting noise exposure through Occupational Safety and Health Administration (OSHA) limits to occupational noise and the wearing of hearing-protection devices (e.g., ear muffs or earplugs). There are no known medications that can be used clinically to prevent NIHL in humans.
LePrell and colleagues have successfully established a protocol for inducing TTS using digitally-modified pop or rock music. This model of experimentally-induced TTS was intended to provide an ethical way of testing medications that might prevent NIHL.
In a mouse model, Bao and colleagues were able to use zonisamide, an anti-epileptic medication approved for the treatment of partial seizures, and methylprednisolone, a glucocorticoid medication, to protect against noise-induced PTS. The long-term goal of this research is to find medications that can prevent NIHL. The goal of the present pilot study is to evaluate zonisamide and methylprednisolone as medications to prevent TTS in humans.
Specific Aim 1: Examine zonisamide as a possible prophylactic medication to prevent noise-induced hearing loss, using an escalating dose protocol. Healthy volunteers would be given 100 or 200 mg of zonisamide as one-time doses or as a daily medication for two week (to establish a steady-state). They would be exposed to digitally-modified pop or rock music for 4 hours and undergo serial testing of hearing and monitoring for side effects after their sound exposure for 3-4 hours. They would be monitored at one day and one week post-exposure for hearing and other side effects.
Hypothesis: Zonisamide is able to protect against noise-induced hearing loss in humans.
Specific Aim 2: Examine methylprednisolone as a possible prophylactic medication to prevent noise-induced hearing loss, using an escalating dose protocol. Healthy volunteers would be given 32 or 64 mg of methylprednisolone as one-time doses. They would undergo the same music exposure and post-sound exposure monitoring as described above.
Hypothesis: Methylprednisolone is able to protect against noise-induced hearing loss in humans
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss |
Actual Study Start Date : | October 31, 2017 |
Actual Primary Completion Date : | November 1, 2017 |
Actual Study Completion Date : | November 1, 2017 |

Arm | Intervention/treatment |
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Experimental: Zonisamide
Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
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Drug: Zonisamide
Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
Other Name: Zonegran |
Experimental: Methylprednisolone
Methylprednisolone 32 mg or 64 mg pill administered orally once
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Drug: Methylprednisolone
Methylprednisolone 32 mg or 64 mg pill administered orally once
Other Names:
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No Intervention: Control
no medication
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- Pure Tone Thresholds [ Time Frame: 15 minutes post-music exposure ]The primary outcome will be pure tone hearing thresholds (particularly 2000, 3000, 4000, and 6000 Hz) as measured by audiogram in a soundproof booth.
- DPOAE [ Time Frame: visit 2, pre-music exposure; visit 3-one week after music exposure ]Distortion-product otoacoustic emissions (DPOAE) will be used as a secondary auditory outcome. A tinnitus questionnaire (Tinnitus Handicap Inventory) will be used to measure the secondary outcome of tinnitus, which frequently accompanies TTS.
- Pure tone thresholds [ Time Frame: 1 hr 15 min, 2 hr 15 min, and 3 hr 15 min post exposure. ]This outcome measures recovery of hearing after loud music exposure
- Pure tone thresholds [ Time Frame: One week after music exposure. ]Recovery of hearing after noise exposure

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- adults 18 to 30 years old
- normal hearing
- good to excellent health
Exclusion Criteria:
- hearing loss
- history of seizures
- history of allergy or hypersensitivity to sulfonamide or oral steroid medications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049073
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Judith Lieu, MD | Washington University School of Medicine |
Responsible Party: | Judith Lieu, Associate Professor of Otolaryngology, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT02049073 |
Other Study ID Numbers: |
NIHL2014 |
First Posted: | January 29, 2014 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
hearing loss noise induced hearing loss zonisamide |
Hearing Loss Deafness Hearing Loss, Noise-Induced Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Hearing Loss, Sensorineural Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate |
Zonisamide Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal |