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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014