NCT01820416

The Effect of Low-Level Laser Stimulation on Hearing Thresholds

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
RADIATION	Low-level Laser Therapy	Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds.
OTHER	Placebo Comparator: Disabled Laser	Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2013-03-28
• Last updated: 2017-06-01
• Results posted: 2017-06-01

Locations

1 site across 1 country: United States