Study of Low Level Laser Therapy and Tinnitus Relief

This study has been terminated.
(New information suggested a more effective treatment protocol.)
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00845975
First received: February 16, 2009
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.


Condition Intervention
Tinnitus
Device: Hearing Laser#1
Device: Hearing Laser #2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Randomized Evaluation of the Application of Low Level Laser Light Therapy Using the Erchonia Hearing Lasers for the Relief of Tinnitus Clinical Study Protocol.

Resource links provided by NLM:


Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • Change from baseline to study endpoint in the Total score on the Tinnitus Handicap Inventory (THI). [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory-II (BDI-II)Spielberger State-Trait Anxiety Inventory - Trait portion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Device: Hearing Laser #2
Comparison of active low level light therapy lasers with placebo devices.
Experimental: B Device: Hearing Laser#1
Comparison of active low level light therapy lasers with placebo devices.

Detailed Description:

Tinnitus is the perception of sound, such as a ringing or hissing, that occurs in the ears or head in the absence of external stimuli. About 40-50 million people in the United States report experiencing tinnitus; 10-12 million have sought medical help for their tinnitus, with 2.5 million reporting their tinnitus as debilitating. As a result of the distressing nature of tinnitus, it is often accompanied by anxiety, depression and sleep difficulties.

Tinnitus is most often caused by sensorineural hearing loss due to presbyacusis (aging) or noise damage. It is believed that the tinnitus results when spurious neuro-electrical signals are produced by diseased, degenerated or damaged cochlear hair cells and interpreted by the brain as tinnitus.

There is presently no cure for tinnitus. Current management strategies include using other external sounds to distract from the tinnitus, teaching relaxation and stress reduction techniques, and prescription medications to help ease stress, anxiety, depression and sleep difficulties. However, in general, current tinnitus management techniques are only minimally effective. It is believed that low level laser light therapy may offer a simple, non-invasive means of relieving the symptoms of tinnitus. In theory, low level laser light penetrates targeted tissues to stimulate the mitochondria in underlying cells to produce energy through the production of ATP (adenosine triphosphate). In turn, the enhanced ATP fuels cellular energy and enhances blood flow to the cochlear hair cells (cilia) to assists in regulating the electrical signals disrupted by the diseased and/or degenerated cochlear hair cells. With the taming of the spurious electrical signals, the brain no longer has a basis to perceive the noise known as tinnitus.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Total score on the Tinnitus Handicap Inventory (THI) of at least 20.
  • Tinnitus is on-going; present for more than 50% of the time over the past 6 months.
  • Subject has been previously evaluated by a qualified health care professional for tinnitus and received a diagnosis of etiology of tinnitus related to hearing impairment and/or noise exposure and/or unknown.
  • Any existing hearing loss stable over the past 12 months.
  • Willingness to abstain from partaking in other, non-study procedures indicated to lessen tinnitus and/or its perception, with the exclusion of wearing hearing aids for those subjects who enter the study using hearing aids, throughout the course of study participation.
  • Willing and able to refrain from engaging in activities or work involving loud noise exposure, such as hunting, rock concerts and work situations that involve working around loud machinery, construction sites, etc., throughout the course of study participation.
  • 18 years or older.
  • Male or female.
  • English as primary spoken language.

Exclusion Criteria:

  • Presence of any of the following or in the subject's medical history:
  • physical trauma or surgery to the head or neck
  • uncontrolled hypertension
  • current or prior surgically removed acoustic neuroma middle ear infection/active drainage from the ear and/or history of either within the previous 90 days
  • impacted cerumen
  • thyroid disease
  • vascular disorders
  • TMJ disorder
  • nutritional deficiency
  • aneurysm
  • multiple sclerosis
  • Episodic or infrequent tinnitus
  • Somatic or pulsatile tinnitus
  • Prior history of sudden hearing loss and/or fluctuating hearing levels .
  • Consistent use of any of the following drugs within the past 30 days:

NSAIDS; aspirin and other salicylates; Lasix and ther "loop"diuretics; "mycin" antibiotics such as vancomycin; quinine and related drugs; Chemotherapy agents such as cis-platin.

  • Acute or chronic vertigo/dizziness.
  • Prior diagnosis of central auditory processing disorder.
  • Ménière's disease.
  • Tympanic membrane perforation or tubes.
  • Prior stapedectomy
  • Prior mastoidectomy.
  • Otosclerosis.
  • Otosyphilis.
  • Labyrinthitis.
  • Auditory nerve damage.
  • Stapedius myoclonus syndrome.
  • Brain and/or brainstem injury.
  • Cochlear implant.
  • Photosensitivity disorder.
  • Active/open infection, wound or other external trauma to the areas to be treated with the Hearing Laser.
  • Pregnant or lactating.
  • Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
  • Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
  • History of drug or alcohol abuse.
  • Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
  • Participation in research in the past 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845975

Locations
United States, California
McDonald Hearing Aid Center
Sacramento, California, United States, 95825
Sponsors and Collaborators
Erchonia Corporation
Investigators
Principal Investigator: Louis A Looper, MA, CCC-A McDonald Hearing Aid Centers
  More Information

No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00845975     History of Changes
Other Study ID Numbers: TS-001
Study First Received: February 16, 2009
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014