Study Stopped
new data makes this trial unethical
Prevention of Noise-induced Hearing Loss
Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 6, 2017
November 1, 2017
1 day
January 23, 2014
November 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pure Tone Thresholds
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 Outcomes (2)
DPOAE
visit 2, pre-music exposure; visit 3-one week after music exposure
Pure tone thresholds
1 hr 15 min, 2 hr 15 min, and 3 hr 15 min post exposure.
Other Outcomes (1)
Pure tone thresholds
One week after music exposure.
Study Arms (3)
Zonisamide
EXPERIMENTALZonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
Methylprednisolone
EXPERIMENTALMethylprednisolone 32 mg or 64 mg pill administered orally once
Control
NO INTERVENTIONno medication
Interventions
Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
Methylprednisolone 32 mg or 64 mg pill administered orally once
Eligibility Criteria
You may qualify if:
- adults 18 to 30 years old
- normal hearing
- good to excellent health
You may not qualify if:
- hearing loss
- history of seizures
- history of allergy or hypersensitivity to sulfonamide or oral steroid medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith Lieu, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Otolaryngology
Study Record Dates
First Submitted
January 23, 2014
First Posted
January 29, 2014
Study Start
October 31, 2017
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
November 6, 2017
Record last verified: 2017-11