Prevention of Noise-induced Hearing Loss

November 2, 2017 updated by: Judith Lieu, Washington University School of Medicine

Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zonisamide
Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
Drug: Zonisamide
Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
Other Names:
  • Zonegran
Experimental: Methylprednisolone
Methylprednisolone 32 mg or 64 mg pill administered orally once
Drug: Methylprednisolone
Methylprednisolone 32 mg or 64 mg pill administered orally once
Other Names:
  • Depo-Medrol
  • Medrol
  • Solu-Medrol
  • Hybrisil
  • A-Methapred
No Intervention: Control
no medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes post-music exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
visit 2, pre-music exposure; visit 3-one week after music exposure
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
1 hr 15 min, 2 hr 15 min, and 3 hr 15 min post exposure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pure tone thresholds
Time Frame: One week after music exposure.
Recovery of hearing after noise exposure
One week after music exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Judith Lieu, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIHL2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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