The Effect of Low-Level Laser Stimulation on Hearing Thresholds

Hearing Loss Clinical Trial

Official title:

The Effect of Low-Level Laser Stimulation on Hearing Thresholds

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820416
• Other study ID #: 200808718
• Status: Terminated
• Phase: N/A
• First received: March 25, 2013
• Last updated: March 25, 2013
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2013
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	GN Resound

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hearing Status	Hearing status assessed by test battery: standard hearing test (audiogram), tympanograms, otoacoustic emissions, speech perception.	one week later after baseline	No