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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
Islamic Azad University of Mashhad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Tinnitus focused on measuring Tinnitus, Low power laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 29, 2010
    Last Updated
    December 29, 2010
    Sponsor
    Islamic Azad University of Mashhad
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    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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