Efficacy and Safety of Low-Level Light Therapy in Tinnitus
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0002898
- Lead Sponsor
- Dankook Univeristy Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Aged = 19 years
2. Unilateral subjective tinnitus symptoms for more than 3 months (If the subject has bilateral tinnitus, subject who has dominant symptom between two ears could be enrolled.)
3. Averaged hearing thresholds > 15 dB at 3000, 4000, or 6000 Hz
4. Subject who did not take any medication for tinnitus one month before enrollment
5. Consent to and willing to discontinue medication for tinnitus (eg, Ginkgo-Biloba, Tanamin, etc.) during this trial
6. Women of childbearing age who are confirmed by negative in pregnancy test and who agree to use the contraceptive device during the study
7. Those who agree not to receive any treatment on the ear during the period of clinical trial participation
8. Those who voluntarily participate in the trial and are willing to follow the protocol
9. Those who have fully understood the written consensus
1. In the cases that the tinnitus has definite cuase (acoustic neurinoma, cerebral tumor, cerebral vessel malformation, vascular tinnitus, tinnitus induced by muscle contraction)
2. Those with history of conductive hearing loss, perforation of the eardrum, etc.
3. Experiences of ototoxic drugs, those who have had meningitis
4. Those who have ear diseases such as external otitis, ear canal occlusion, otitis media
5. Any person who has had a serious disease in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or a mental illness
6. Anyone who is sensitive to light
7. Women of childbearing age who do not agree to contraception during the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method numerical rating scale for loduness, duration, annoyance;THI (Tinnitus Handicap Inventory) Questionnaire;tinnitogram (loudness, MML);Safety
- Secondary Outcome Measures
Name Time Method tinnitogram (pitch)