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

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Brief Title

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

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 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

Interventional


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.


Condition

Sensorineural Hearing Loss

Intervention

The Hearing Laser

Study Arms / Comparison Groups

 The Hearing Laser
Description:  Active low level laser light therapy of 635 nanometers (nm)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

80

Start Date

August 2007

Completion Date

June 2008

Primary Completion Date

June 2008

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Betty McNamara, M.S., CCC-A, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00787189

Organization ID

EHL-001


Responsible Party

Sponsor

Study Sponsor

Erchonia Corporation


Study Sponsor

Betty McNamara, M.S., CCC-A, Principal Investigator, Maryjane Rees Language Speech & Hearing Center


Verification Date

January 2020