The Effect of Low-Level Laser Stimulation on Hearing Thresholds

NCT01820416 | Terminated Results

• 1 other identifier: 200808718
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Hearing Loss, Bilateral; Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• 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.

  7-10 days after baseline measures recorded

Study Arms (3)

Low-Level Laser Therapy

EXPERIMENTAL

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

Disabled Laser

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.

Interventions

Low-level Laser Therapy RADIATION

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.

Also known as: Erchonia EHL laser (Erchonia Medical, Inc.)

Low-Level Laser Therapy

Placebo Comparator: Disabled Laser OTHER

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.

Disabled Laser

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral sensorineural hearing loss
• normal middle ear status

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• GN Resound: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 24024040 DERIVED

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Bilateral; Hearing Loss, Sensorineural

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Shawn S Goodman
• Organization: Dept. of Communication Sciences & Disorders, University of Iowa

shawn-goodman@uiowa.edu

319-335-8700

Study Officials

• Shawn S Goodman, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: March 28, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-04

Locations

US (1)