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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00787189
First received: November 6, 2008
Last updated: April 7, 2014
Last verified: April 2014
  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
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:


Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tinnitus, Hearing-related Quality of Life [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
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
Active Comparator: The Hearing Laser
Active low level laser light therapy of 635 nanometers (nm)
Device: The Hearing Laser
Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
Placebo Comparator: Placebo Laser
inactive low level laser light therapy with no therapeutic output
Device: Placebo Laser
inactive low level laser light therapy with no therapeutic output

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Corporation
Investigators
Principal Investigator: Betty McNamara, M.S., CCC-A Maryjane Rees Language Speech & Hearing Center
  More Information

No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00787189     History of Changes
Other Study ID Numbers: EHL-001
Study First Received: November 6, 2008
Results First Received: June 23, 2009
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Erchonia Corporation:
sensorineural hearing loss
tinnitus
word recognition

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Sensorineural
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014