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: DPOAEPure 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
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