Study using the App for Tinnitus Treatment in Patients with Tinnitus.

JRCT ID: jRCTs032230359

Registered date:25/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic tinnitus with associated suffering
• Date of first enrollment: 02/11/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Treatment group: App content for 16 weeks.
Control group: App content for 16 weeks.

Outcome(s)

• Primary Outcome: Change in THI total score from week 0 at week 16 after study app prescription.

Secondary Outcome

THI score
TFI score
NRS score
HADS depression score
HADS anxiety score
AIS score
PGI-I score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Wasano Koichiro
• Source(s) of Monetary Support: KYORIN Pharmaceutical Co.,Ltd.