The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Primary Purpose
Hearing Loss
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-level Laser Therapy
Placebo Comparator: Disabled Laser
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- bilateral sensorineural hearing loss
- normal middle ear status
Exclusion Criteria:
- pregnant or lactating
- serious mental health illness or medical/psychiatric hospitalization
- treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
- taking Aspirin, Ibuprofen, Naprosyn, Aleve
- taking any Quinine-related drugs
- taking any loop diuretics
- have a developmental disability or cognitive impairment
- history of drug abuse
- involved in litigation or claim related to hearing loss
- regularly exposed to significant occupational or recreational noise
- have a photosensitivity disorder
- have a retinal disease
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Low-Level Laser Therapy
Disabled Laser
Control
Arm Description
Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
Outcomes
Primary Outcome Measures
Change in Speech Perception
Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.
Secondary Outcome Measures
Full Information
NCT ID
NCT01820416
First Posted
March 25, 2013
Last Updated
April 26, 2017
Sponsor
University of Iowa
Collaborators
GN Resound
1. Study Identification
Unique Protocol Identification Number
NCT01820416
Brief Title
The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Official Title
The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Analysis showed no clinically or statistically significant effects
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
GN Resound
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. Subjects will be randomly assigned to a treatment, placebo, or control group. The treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. The laser beams are cool to the touch, and do not cause discomfort. Each laser treatment will last approximately 4 minutes. Three treatments will be applied three times within the course of one week. Hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. Results will be analyzed to determine the effect of the laser treatment on hearing.
Detailed Description
Low-level laser therapy has been practiced for about 20 years in Europe and is beginning to be practiced in the US. Theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. The effects of low-level laser therapy on hearing have not been well studied. It has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. Studies of low-level laser stimulation of cochleae utilizing microscopy, PET imaging, and MRI suggest potential therapeutic benefit to hearing. While preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Loss, Bilateral, Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Level Laser Therapy
Arm Type
Experimental
Arm Description
Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Arm Title
Disabled Laser
Arm Type
Placebo Comparator
Arm Description
Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
Intervention Type
Radiation
Intervention Name(s)
Low-level Laser Therapy
Other Intervention Name(s)
Erchonia EHL laser (Erchonia Medical, Inc.)
Intervention Description
Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: Disabled Laser
Intervention Description
Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation.
Primary Outcome Measure Information:
Title
Change in Speech Perception
Description
Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.
Time Frame
7-10 days after baseline measures recorded
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bilateral sensorineural hearing loss
normal middle ear status
Exclusion Criteria:
pregnant or lactating
serious mental health illness or medical/psychiatric hospitalization
treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
taking Aspirin, Ibuprofen, Naprosyn, Aleve
taking any Quinine-related drugs
taking any loop diuretics
have a developmental disability or cognitive impairment
history of drug abuse
involved in litigation or claim related to hearing loss
regularly exposed to significant occupational or recreational noise
have a photosensitivity disorder
have a retinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn S Goodman, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24024040
Citation
Goodman SS, Bentler RA, Dittberner A, Mertes IB. The effect of low-level laser therapy on hearing. ISRN Otolaryngol. 2013 Apr 23;2013:916370. doi: 10.1155/2013/916370. eCollection 2013.
Results Reference
derived
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The Effect of Low-Level Laser Stimulation on Hearing Thresholds
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