Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals - Full Text View

Sponsor:	Erchonia Medical, Inc.
Information provided by:	Erchonia Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00787189

Purpose

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.

Condition	Intervention
Sensorineural Hearing Loss	Device: The Hearing Laser Device: Placebo Laser

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Disorders and Deafness Tinnitus

U.S. FDA Resources

Further study details as provided by Erchonia Medical, Inc.:

Primary Outcome Measures:

word recognition scores [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

tinnitus, hearing-related quality of life [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Active and placebo laser devices	Device: The Hearing Laser Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
B: Placebo Comparator Active and placebo laser devices	Device: Placebo Laser

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787189

Locations

United States, California
McDonald Hearing Centers
Sacramento, California, United States, 95818

Sponsors and Collaborators

Erchonia Medical, Inc.

Investigators

Principal Investigator:

Betty McNamara, M.S., CCC-A

Maryjane Rees Language Speech & Hearing Center

More Information

No publications provided

Responsible Party:	Erchonia Medical, Inc. ( Steven Shanks, President )
ClinicalTrials.gov Identifier:	NCT00787189 History of Changes
Other Study ID Numbers:	EHL-001, HMED-001
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Erchonia Medical, Inc.:

sensorineural hearing loss
tinnitus
word recognition

Additional relevant MeSH terms:

Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases

Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 01, 2010