Evaluation of Low Dose Laser in Treatment of Tinnitus

Subjective Tinnitus Clinical Trial

Official title:

Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268449
• Other study ID #: Laser-tinnitus-202
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2010
• Last updated: December 29, 2010
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: Islamic Azad University of Mashhad
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

Radiation:
• Low dose laser
5mv laser with a wavelength of 650nm
• Placebo
The act of radiating laser to the ear is done while the set is off.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University of Mashhad