Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

NCT00787189 | Completed Results DMC

• 1 other identifier: EHL-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss

Keywords

sensorineural hearing loss; tinnitus; word recognition

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. 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.

  baseline and one week

Study Arms (2)

The Hearing Laser

ACTIVE COMPARATOR

Active low level laser light therapy of 635 nanometers (nm)

Device: The Hearing Laser

Placebo Laser

PLACEBO COMPARATOR

inactive low level laser light therapy with no therapeutic output

Device: Placebo Laser

Interventions

The Hearing Laser DEVICE

Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.

The Hearing Laser

Placebo Laser DEVICE

inactive low level laser light therapy with no therapeutic output

Placebo Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sensorineural hearing loss.
• Mild or greater degree.
• Adult onset.
• Gradual onset.
• Hearing loss stable over past 12 months.
• Etiology of presbyacusis or noise-induced hearing loss.
• Unaided word recognition score between 28% and 86%.
• English as primary spoken language.
• Willing and able to abstain from other treatments or medications to improve hearing ability.
• Willing and able to abstain from work or other activities that involve loud noise exposure.

You may not qualify if:

• Central auditory processing disorder.
• Active/recurrent middle ear infection.
• Meniere's disease.
• Tympanic membrane perforation/tubes.
• Cochlear implant.
• Removal of acoustic neuroma.
• Hyperacusis/misphonia.
• Photosensitivity disorder.
• Active infection/wound in head/ear region.
• Pregnant/lactating.
• Serious mental health illness.
• Significant developmental disability/cognitive impairment.
• History of drug/alcohol abuse.
• Involvement in litigation/worker's compensation/disability benefits for hearing loss.
• Other research participation in past 90 days.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

McDonald Hearing Centers

Sacramento, California, 95818, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Tinnitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Betty McNamara, M.S., CCC-A

  Maryjane Rees Language Speech & Hearing Center

  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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 28, 2021
• Results First Posted: July 11, 2011

Record last verified: 2021-05

Locations

US (1)