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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Recruitment Status : Withdrawn (new data makes this trial unethical)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
Sponsor:
Information provided by (Responsible Party):
Judith Lieu, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 23, 2014
First Posted Date  ICMJE January 29, 2014
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE October 31, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 27, 2014)
Pure tone thresholds [ Time Frame: One week after music exposure. ]
Recovery of hearing after noise exposure
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prevention of Noise-induced Hearing Loss
Official Title  ICMJE Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Noise-induced Hearing Loss
Intervention  ICMJE
  • Drug: Zonisamide
    Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
    Other Name: Zonegran
  • Drug: Methylprednisolone
    Methylprednisolone 32 mg or 64 mg pill administered orally once
    Other Names:
    • Medrol
    • Solu-Medrol
    • Depo-Medrol
    • Hybrisil
    • A-Methapred
Study Arms  ICMJE
  • Experimental: Zonisamide
    Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
    Intervention: Drug: Zonisamide
  • Experimental: Methylprednisolone
    Methylprednisolone 32 mg or 64 mg pill administered orally once
    Intervention: Drug: Methylprednisolone
  • No Intervention: Control
    no medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 2, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2014)
50
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02049073
Other Study ID Numbers  ICMJE NIHL2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party Judith Lieu, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Lieu, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP