The Effect of Low-Level Laser Stimulation on Hearing Thresholds
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|ClinicalTrials.gov Identifier: NCT01820416|
Recruitment Status : Terminated (Analysis showed no clinically or statistically significant effects)
First Posted : March 28, 2013
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Radiation: Low-level Laser Therapy Other: Placebo Comparator: Disabled Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Low-Level Laser Stimulation on Hearing Thresholds|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Low-Level Laser Therapy
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.
Radiation: Low-level Laser Therapy
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.
Other Name: Erchonia EHL laser (Erchonia Medical, Inc.)
Placebo Comparator: Disabled Laser
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.
Other: Placebo Comparator: Disabled Laser
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.
No Intervention: Control
Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
- Change in Speech Perception [ Time Frame: 7-10 days after baseline measures recorded ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820416
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Shawn S Goodman, PhD||University of Iowa|