History of Changes for Study: NCT01820416

The Effect of Low-Level Laser Stimulation on Hearing Thresholds

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			March 25, 2013	None (earliest Version on record)
2			April 26, 2017	Study Status, Arms and Interventions, Results and Outcome Measures

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Study Identification


Unique Protocol ID:	200808718
Brief Title:	The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Official Title:	The Effect of Low-Level Laser Stimulation on Hearing Thresholds
Secondary IDs:

Study Status


Record Verification:	March 2013
Overall Status:	Terminated [Analysis showed no clinically or statistically significant effects]
Study Start:	September 2009
Primary Completion:	December 2009 [Actual]
Study Completion:	December 2009 [Actual]

First Submitted:	March 25, 2013
First Submitted that Met QC Criteria:	March 25, 2013
First Posted:	March 28, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	March 25, 2013
Last Update Posted:	March 28, 2013 [Estimate]

Sponsor/Collaborators


Sponsor:	University of Iowa
Responsible Party:	Principal Investigator Investigator: Shawn Goodman Official Title: Assistant Professor Affiliation: University of Iowa
Collaborators:	GN Resound

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

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.

Conditions


Conditions:	Hearing Loss
Keywords:	Hearing Loss, Bilateral Hearing Loss, Sensorineural

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	35 [Actual]

Arms and Interventions

Arms	Assigned Interventions
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 Names: 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.
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.

Outcome Measures


Primary Outcome Measures:
1.	Change in Hearing Status [ Time Frame: one week later after baseline ] Hearing status assessed by test battery: standard hearing test (audiogram), tympanograms, otoacoustic emissions, speech perception.

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Study Officials:	Shawn S Goodman, PhD Principal Investigator University of Iowa
Locations:	United States, Iowa
	University of Iowa Iowa City, Iowa, United States, 52242

IPDSharing


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References


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