Evaluation of Low Dose Laser in Treatment of Tinnitus

NCT ID: NCT01268449

Last Updated: 2010-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Subjective Tinnitus

Keywords

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Tinnitus Low power laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Laser group

Group Type ACTIVE_COMPARATOR

Low dose laser

Intervention Type RADIATION

5mv laser with a wavelength of 650nm

Placebo group

Randomly,half of the patients receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type RADIATION

The act of radiating laser to the ear is done while the set is off.

Interventions

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Low dose laser

5mv laser with a wavelength of 650nm

Intervention Type RADIATION

Placebo

The act of radiating laser to the ear is done while the set is off.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Islamic Azad University of Mashhad

OTHER

Sponsor Role lead

Responsible Party

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Islamic Azad University Mashad Branch

Other Identifiers

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Laser-tinnitus-202

Identifier Type: -

Identifier Source: org_study_id