The Effect of Low-Level Laser Stimulation on Hearing Thresholds

University of Iowa

Status: Terminated

Conditions: Hearing Loss

Treatments: Other: Placebo Comparator: Disabled Laser; Radiation: Low-level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01820416

200808718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• bilateral sensorineural hearing loss
• normal middle ear status

Exclusion criteria

• pregnant or lactating
• serious mental health illness or medical/psychiatric hospitalization
• treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
• taking Aspirin, Ibuprofen, Naprosyn, Aleve
• taking any Quinine-related drugs
• taking any loop diuretics
• have a developmental disability or cognitive impairment
• history of drug abuse
• involved in litigation or claim related to hearing loss
• regularly exposed to significant occupational or recreational noise
• have a photosensitivity disorder
• have a retinal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

Low-Level Laser Therapy

Experimental group

Description:

Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.

Treatment:

Radiation: Low-level Laser Therapy

Disabled Laser

Placebo Comparator group

Description:

Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.

Treatment:

Other: Placebo Comparator: Disabled Laser

Control

No Intervention group

Description:

Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.