Evaluation of Low Dose Laser in Treatment of Tinnitus

This study has been completed.

Sponsor:

Information provided by:

Islamic Azad University of Mashhad

ClinicalTrials.gov Identifier:

NCT01268449

First received: December 29, 2010

Last updated: NA

Last verified: August 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 29, 2010
Last Updated Date	December 29, 2010
Start Date ^ICMJE	March 2008
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Low Dose Laser in Treatment of Tinnitus
Official Title ^ICMJE	Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
Brief Summary	The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Subjective Tinnitus
Intervention ^ICMJE	Radiation: Low dose laser 5mv laser with a wavelength of 650nm Radiation: Placebo The act of radiating laser to the ear is done while the set is off.
Study Arm (s)	Active Comparator: Laser group Intervention: Radiation: Low dose laser Placebo Comparator: Placebo group Randomly,half of the patients receive placebo. Intervention: Radiation: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	66
Completion Date	September 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01268449
Other Study ID Numbers ^ICMJE	Laser-tinnitus-202
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Mahboobeh Adami Dehkordi, Islamic Azad University Mashad Branch
Study Sponsor ^ICMJE	Islamic Azad University of Mashhad
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Islamic Azad University of Mashhad
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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