Noise-induced Hearing Loss Clinical Trial
Official title:
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.
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
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