Clinical Trial: The Effect of Low-Level Laser Stimulation on Hearing Thresholds

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Effect of Low-Level Laser Stimulation on Hearing Thresholds

Brief Summary: The purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. The treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. The laser beams are cool to the touch, and do not cause discomfort. Each laser treatment will last approximately 4 minutes. Three treatments will be applied three times within the course of one week. Hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. Results will be analyzed to determine the effect of the laser treatment on hearing.

Detailed Summary: Low-level laser therapy has been practiced for about 20 years in Europe and is beginning to be practiced in the US. Theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. The effects of low-level laser therapy on hearing have not been well studied. It has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. Studies of low-level laser stimulation of cochleae utilizing microscopy, PET imaging, and MRI suggest potential therapeutic benefit to hearing. While preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.
Sponsor: University of Iowa

Current Primary Outcome: Change in Hearing Status [ Time Frame: one week later after baseline ]

Hearing status assessed by test battery: standard hearing test (audiogram), tympanograms, otoacoustic emissions, speech perception.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Iowa

Dates:
Date Received: March 25, 2013
Date Started: September 2009
Date Completion:
Last Updated: March 25, 2013
Last Verified: March 2013