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Evaluation of Low Dose Laser in Treatment of Tinnitus

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ClinicalTrials.gov Identifier: NCT01268449
Recruitment Status : Completed
First Posted : December 30, 2010
Last Update Posted : December 30, 2010
Sponsor:
Information provided by:
Islamic Azad University of Mashhad

Brief Summary:
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.

Condition or disease Intervention/treatment Phase
Subjective Tinnitus Radiation: Low dose laser Radiation: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
Study Start Date : March 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Laser group Radiation: Low dose laser
5mv laser with a wavelength of 650nm
Placebo Comparator: Placebo group
Randomly,half of the patients receive placebo.
Radiation: Placebo
The act of radiating laser to the ear is done while the set is off.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults older than 18 years old
  • Idiopathic, subjective, unilateral tinnitus with at least 2 month duration

Exclusion Criteria:

  • Patients with chronic otitis media
  • Patients with tympan perforation with any underlying cause
  • Patients with external otitis
  • Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear

Responsible Party: Dr. Mahboobeh Adami Dehkordi, Islamic Azad University Mashad Branch
ClinicalTrials.gov Identifier: NCT01268449     History of Changes
Other Study ID Numbers: Laser-tinnitus-202
First Posted: December 30, 2010    Key Record Dates
Last Update Posted: December 30, 2010
Last Verified: August 2010

Keywords provided by Islamic Azad University of Mashhad:
Tinnitus
Low power laser

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