Status:
TERMINATED
Study of Low Level Laser Therapy and Tinnitus Relief
Lead Sponsor:
Erchonia Corporation
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.
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 experienci...
Eligibility Criteria
Inclusion
- 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
- 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
- Temporomandibular Joint Disorder (TMJD)
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00845975
Start Date
August 1 2008
End Date
November 1 2008
Last Update
June 5 2014
Active Locations (1)
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1
McDonald Hearing Aid Center
Sacramento, California, United States, 95825