NIPH Clinical Trials Search

KRP-DT123 Pivotal Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Tinnitus
Date of first enrollment	02/05/2026
Target sample size	210
Countries of recruitment
Study type	Interventional
Intervention(s)	Treatment Group: Use of treatment app for 16 weeks Control Group: Use of control app for 16 weeks

Outcome(s)

Primary Outcome	Change from baseline on week 16 in the Tinnitus Handicap Inventory (THI) score
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 75age old
Gender	Both
Include criteria	(1)Men or women aged at least 18 years and yonger than 75 years (2)Patients with clinically diagnosed chronic unilateral or bilateral tinnitus. (3)Duration of bothersome tinnitus symptoms at least 3 months but less than 4 years. (4)At least 28 days had elapsed since the patient's initial doctor's visit for tinnitus(eg, intake examination, diagnostic testing, educational counseling).
Exclude criteria	(1)Diagnosed with pulsatile or paroxysmal tinnitus. (2)Complicated by fluctuating hearing loss (e.g., Meniere's disease,low-frequency sensorineuralhearing loss), post-labyrinthine hearing loss (e.g., acoustic neuroma), glomus tumor, or arteriovenous malformation. (3)Comorbid with middle ear disease requiring treatment (e.g., otitis media, otosclerosis, eustachian tube dysfunction) or acute hearing loss. (4)Initiated hearing aid use within 6 months prior to registration (excluding cross hearing aids)