Clinical Trial: Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol

Brief Summary: The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.

Detailed Summary: Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.
Sponsor: Erchonia Corporation

Current Primary Outcome: Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart. [ Time Frame: baseline and one week ]

Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.


Original Primary Outcome: word recognition scores [ Time Frame: one week ]

Current Secondary Outcome: Tinnitus, Hearing-related Quality of Life [ Time Frame: up to 6 months ]

Original Secondary Outcome: Same as current

Information By: Erchonia Corporation

Dates:
Date Received: November 6, 2008
Date Started: August 2007
Date Completion:
Last Updated: April 7, 2014
Last Verified: April 2014