Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00787189 |
Recruitment Status
:
Completed
First Posted
: November 7, 2008
Results First Posted
: July 11, 2011
Last Update Posted
: April 24, 2014
|
Sponsor:
Erchonia Corporation
Information provided by (Responsible Party):
Erchonia Corporation
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |
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 |
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 |
|
|||
Study Arms |
|
|||
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 |
80 | |||
Original Actual Enrollment ICMJE |
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
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 |