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

Tracking Information
First Submitted Date ICMJE	November 6, 2008
First Posted Date ICMJE	November 7, 2008
Results First Submitted Date	June 23, 2009
Results First Posted Date	July 11, 2011
Last Update Posted Date	April 24, 2014
Study Start Date ICMJE	August 2007
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 13, 2011)	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 Measures ICMJE; (submitted: November 6, 2008)	word recognition scores [ Time Frame: one week ]
Change History	Complete list of historical versions of study NCT00787189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 6, 2008)	Tinnitus, Hearing-related Quality of Life [ Time Frame: up to 6 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Official Title ICMJE	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 Description	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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Sensorineural Hearing Loss
Intervention ICMJE	Device: The Hearing Laser Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.; Device: Placebo Laser inactive low level laser light therapy with no therapeutic output
Study Arms	Active Comparator: The Hearing Laser Active low level laser light therapy of 635 nanometers (nm) Intervention: Device: The Hearing Laser; Placebo Comparator: Placebo Laser inactive low level laser light therapy with no therapeutic output Intervention: Device: Placebo Laser
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 13, 2011)	80
Original Actual Enrollment ICMJE; (submitted: November 6, 2008)	70
Actual Study Completion Date	June 2008
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Sensorineural hearing loss.; Mild or greater degree.; Adult onset.; Gradual onset.; Hearing loss stable over past 12 months.; Etiology of presbyacusis or noise-induced hearing loss.; Unaided word recognition score between 28% and 86%.; English as primary spoken language.; Willing and able to abstain from other treatments or medications to improve hearing ability.; Willing and able to abstain from work or other activities that involve loud noise exposure. Exclusion Criteria: Central auditory processing disorder.; Active/recurrent middle ear infection.; Meniere's disease.; Tympanic membrane perforation/tubes.; Cochlear implant.; Removal of acoustic neuroma.; Hyperacusis/misphonia.; Photosensitivity disorder.; Active infection/wound in head/ear region.; Pregnant/lactating.; Serious mental health illness.; Significant developmental disability/cognitive impairment.; History of drug/alcohol abuse.; Involvement in litigation/worker's compensation/disability benefits for hearing loss.; Other research participation in past 90 days.; Use of ototoxic medications known to cause temporary or permanent hearing loss.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00787189
Other Study ID Numbers ICMJE	EHL-001
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Erchonia Corporation
Study Sponsor ICMJE	Erchonia Corporation
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Betty McNamara, M.S., CCC-A Maryjane Rees Language Speech & Hearing Center
PRS Account	Erchonia Corporation
Verification Date	April 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP