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

NCT ID: NCT00787189

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-06-30

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.

Detailed Description

Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The Hearing Laser

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

Group Type: ACTIVE_COMPARATOR

The Hearing Laser

Intervention Type: DEVICE

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

Placebo Laser

inactive low level laser light therapy with no therapeutic output

Group Type: PLACEBO_COMPARATOR

Placebo Laser

Intervention Type: DEVICE

inactive low level laser light therapy with no therapeutic output

Interventions

The Hearing Laser

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

Intervention Type: DEVICE

Placebo Laser

inactive low level laser light therapy with no therapeutic output

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Use of ototoxic medications known to cause temporary or permanent hearing loss.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty McNamara, M.S., CCC-A

Role: PRINCIPAL_INVESTIGATOR

Maryjane Rees Language Speech & Hearing Center

Locations

McDonald Hearing Centers

Sacramento, California, United States

Countries

United States

Other Identifiers

EHL-001

Identifier Type: -

Identifier Source: org_study_id