- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01268449
Evaluation of Low Dose Laser in Treatment of Tinnitus
December 29, 2010 updated by: Islamic Azad University of Mashhad
Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laser group
|
5mv laser with a wavelength of 650nm
|
Placebo Comparator: Placebo group
Randomly,half of the patients receive placebo.
|
The act of radiating laser to the ear is done while the set is off.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 29, 2010
First Submitted That Met QC Criteria
December 29, 2010
First Posted (Estimate)
December 30, 2010
Study Record Updates
Last Update Posted (Estimate)
December 30, 2010
Last Update Submitted That Met QC Criteria
December 29, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laser-tinnitus-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjective Tinnitus
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
Technical University of DenmarkCompleted
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Otonomy, Inc.CompletedSubjective TinnitusUnited States, United Kingdom, Germany, Poland
-
Otonomy, Inc.Completed
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Cairo UniversityCompleted
-
Medical University of LodzCompleted
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Pansatori GmbHCompetence Center for Medical Devices GmbHUnknown
-
Tel-Aviv Sourasky Medical CenterCompleted
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Eye & ENT Hospital of Fudan UniversityUnknown
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