Prevention of Noise-induced Hearing Loss

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Judith Lieu, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02049073
First received: January 23, 2014
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Noise-induced Hearing Loss
Drug: Zonisamide
Drug: Methylprednisolone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Pure Tone Thresholds [ Time Frame: 15 minutes post-music exposure ] [ Designated as safety issue: No ]
    The primary outcome will be pure tone hearing thresholds (particularly 2000, 3000, 4000, and 6000 Hz) as measured by audiogram in a soundproof booth.


Secondary Outcome Measures:
  • DPOAE [ Time Frame: visit 2, pre-music exposure; visit 3-one week after music exposure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    This outcome measures recovery of hearing after loud music exposure


Other Outcome Measures:
  • Pure tone thresholds [ Time Frame: One week after music exposure. ] [ Designated as safety issue: Yes ]
    Recovery of hearing after noise exposure


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Medrol
  • Solu-Medrol
  • Depo-Medrol
  • Hybrisil
  • A-Methapred
No Intervention: Control
no medication

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049073

Contacts
Contact: Judith Lieu, MD 314-454-2197 lieuj@ent.wustl.edu
Contact: Banan Ead, MA 314-454-2197 eadb@ent.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Judith Lieu, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Judith Lieu, MD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: Judith Lieu, Associate Professor of Otolaryngology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02049073     History of Changes
Other Study ID Numbers: NIHL2014
Study First Received: January 23, 2014
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
hearing loss
noise induced hearing loss
zonisamide

Additional relevant MeSH terms:
Hearing Loss, Noise-Induced
Deafness
Hearing Loss
Ear Diseases
Hearing Disorders
Hearing Loss, Sensorineural
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Zonisamide
Anti-Inflammatory Agents
Anticonvulsants
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antioxidants
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 29, 2014