Study using the App for Tinnitus Treatment in Patients with Tinnitus.
- Conditions
- Chronic tinnitus with associated suffering
- Registration Number
- JPRN-jRCTs032230359
- Lead Sponsor
- Wasano Koichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1)Outpatients between 18 and 75 years of age at the time of obtaining consent (regardless of gender).
2)Patients with clinically diagnosed chronic unilateral or bilateral tinnitus.
3)Patients who own a smartphone or other device that meets the required OS version (iOS 14.0 or higher, Android 6.0 or higher) and agree to use it for this study.
4)Patients who speak Japanese on a daily basis and determined to have sufficient reading comprehension ability to use the study app by the principal investigator.
1)Patients with middle ear disease (otitis media, otosclerosis, eustachian tube dysfunction, etc.)or acute hearing loss necessitating treatment.
2)Patients scheduled for or requiring hospitalization or surgical procedures with anesthesia during the study period.
3)Patients with a history of severe psychiatric disorders, (such as severe depression, suicidal ideation, or suicide attempts) or with depression or other psychiatric disorders that are uncontrolled with current medication at certain doses.
4)Patients with clinically significant cardiac, renal, hepatic, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematology, or metabolic disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in THI total score from week 0 at week 16 after study app prescription.
- Secondary Outcome Measures
Name Time Method THI score<br>TFI score<br>NRS score<br>HADS depression score<br>HADS anxiety score<br>AIS score<br>PGI-I score