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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
  Purpose

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


Condition Intervention Phase
Subjective Tinnitus
 Radiation: Low dose laser
Radiation: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by Islamic Azad University of Mashhad:

Enrollment: 66
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: December 29, 2010
Last Updated: December 29, 2010
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013