Back to resultsStudy of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Hearing Laser
Placebo Laser
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring sensorineural hearing loss, tinnitus, word recognition
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.
Sites / Locations
- McDonald Hearing Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
The Hearing Laser
Placebo Laser
Arm Description
Active low level laser light therapy of 635 nanometers (nm)
inactive low level laser light therapy with no therapeutic output
Outcomes
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.
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 Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00787189
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
sensorineural hearing loss, tinnitus, word recognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Hearing Laser
Arm Type
Active Comparator
Arm Description
Active low level laser light therapy of 635 nanometers (nm)
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
inactive low level laser light therapy with no therapeutic output
Intervention Type
Device
Intervention Name(s)
The Hearing Laser
Intervention Description
Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
Intervention Type
Device
Intervention Name(s)
Placebo Laser
Intervention Description
inactive low level laser light therapy with no therapeutic output
Primary Outcome Measure Information:
Title
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.
Description
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 Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. 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.
Time Frame
baseline and one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty McNamara, M.S., CCC-A
Organizational Affiliation
Maryjane Rees Language Speech & Hearing Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
McDonald Hearing Centers
City
Sacramento
State/Province
California
ZIP/Postal Code
95818
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
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