NCT00845975

Study of Low Level Laser Therapy and Tinnitus Relief

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.

Detailed description

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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	Erchonia Hearing Lasers #1 & #2	Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site.
DEVICE	Placebo Lasers	The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light.

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2009-02-18
• Last updated: 2014-06-05
• Results posted: 2014-06-05

Locations

1 site across 1 country: United States