Chronic tinnitus with associated suffering
Conditions
Interventions
Treatment group: App content for 16 weeks.
Control group: App content for 16 weeks.
Sponsors
Wasano Koichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in THI total score from week 0 at week 16 after study app prescription. | — |
Secondary
| Measure | Time frame |
|---|---|
| THI score TFI score NRS score HADS depression score HADS anxiety score AIS score PGI-I score | — |
Contacts
Public ContactKoichiro Wasano
Tokai University Hospital
Outcome results
None listed