Tinnitus Clinical Trial
Official title:
A Double-blind, Placebo-controlled Randomized Evaluation of the Application of Low Level Laser Light Therapy Using the Erchonia Hearing Lasers for the Relief of Tinnitus Clinical Study Protocol.
The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.
Tinnitus is the perception of sound, such as a ringing or hissing, that occurs in the ears
or head in the absence of external stimuli. About 40-50 million people in the United States
report experiencing tinnitus; 10-12 million have sought medical help for their tinnitus,
with 2.5 million reporting their tinnitus as debilitating. As a result of the distressing
nature of tinnitus, it is often accompanied by anxiety, depression and sleep difficulties.
Tinnitus is most often caused by sensorineural hearing loss due to presbyacusis (aging) or
noise damage. It is believed that the tinnitus results when spurious neuro-electrical
signals are produced by diseased, degenerated or damaged cochlear hair cells and interpreted
by the brain as tinnitus.
There is presently no cure for tinnitus. Current management strategies include using other
external sounds to distract from the tinnitus, teaching relaxation and stress reduction
techniques, and prescription medications to help ease stress, anxiety, depression and sleep
difficulties. However, in general, current tinnitus management techniques are only minimally
effective. It is believed that low level laser light therapy may offer a simple,
non-invasive means of relieving the symptoms of tinnitus. In theory, low level laser light
penetrates targeted tissues to stimulate the mitochondria in underlying cells to produce
energy through the production of adenosine triphosphate (ATP). In turn, the enhanced ATP
fuels cellular energy and enhances blood flow to the cochlear hair cells (cilia) to assists
in regulating the electrical signals disrupted by the diseased and/or degenerated cochlear
hair cells. With the taming of the spurious electrical signals, the brain no longer has a
basis to perceive the noise known as tinnitus.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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