Evaluation of Low Dose Laser in Treatment of Tinnitus
Primary Purpose
Subjective Tinnitus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Low dose laser
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subjective Tinnitus focused on measuring Tinnitus, Low power laser
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Laser group
Placebo group
Arm Description
Randomly,half of the patients receive placebo.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01268449
First Posted
December 29, 2010
Last Updated
December 29, 2010
Sponsor
Islamic Azad University of Mashhad
1. Study Identification
Unique Protocol Identification Number
NCT01268449
Brief Title
Evaluation of Low Dose Laser in Treatment of Tinnitus
Official Title
Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Islamic Azad University of Mashhad
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus
Keywords
Tinnitus, Low power laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser group
Arm Type
Active Comparator
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Randomly,half of the patients receive placebo.
Intervention Type
Radiation
Intervention Name(s)
Low dose laser
Intervention Description
5mv laser with a wavelength of 650nm
Intervention Type
Radiation
Intervention Name(s)
Placebo
Intervention Description
The act of radiating laser to the ear is done while the set is off.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Low Dose Laser in Treatment of Tinnitus
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