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Prevention of Noise-induced Hearing Loss

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Noise-induced Hearing Loss

Intervention: Zonisamide (Drug); Methylprednisolone (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Judith Lieu, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Judith Lieu, MD, Phone: 314-454-2197, Email: lieuj@ent.wustl.edu

Summary

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.

Clinical Details

Official title: Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pure Tone Thresholds

Secondary outcome:

DPOAE

Pure tone thresholds

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Judith Lieu, MD, Phone: 314-454-2197, Email: lieuj@ent.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Not yet recruiting
Judith Lieu, MD, Principal Investigator
Additional Information

Starting date: June 2016
Last updated: December 16, 2014

Page last updated: August 23, 2015

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