Clinical trial NCT01820416: The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Official title: The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Loss, Bilateral
Hearing Loss, Sensorineural
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: GN Resound
First posted: 2013-03-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Speech Perception
timeFrame: 7-10 days after baseline measures recorded
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Shawn S Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodman SS, Bentler RA, Dittberner A, Mertes IB. The effect of low-level laser therapy on hearing. ISRN Otolaryngol. 2013 Apr 23;2013:916370. doi: 10.1155/2013/916370. eCollection 2013.