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DIGITAL THERAPEUTICS FOR CHRONIC SUBJECTIVE TINNITUS : KOREAN MULTICENTER RCT
OTORHINOLARYNGOLOGY-HEAD AND NECK SURGERY, SEOUL NATIONAL UNIVERSITY HOSPITAL1,OTORHINOLARYNGOLOGY-HEAD AND NECK SURGERY, KOREA UNIVERSITY GURO HOSPITAL2, OTORHINOLARYNGOLOGY-HEAD AND NECK SURGERY, KOREA UNIVERSITY ANAM HOSPITAL3, OTORHINOLARYNGOLOGY-HEAD AND NECK SURGERY, EWHA WOMANS UNIVERSITY SEOUL HOSPITAL4, OTORHINOLARYNGOLOGY-HEAD AND NECK SURGERY CHONNAM NATIONAL UNIVERSITY HOSPITAL5
JAE-JUN SONG, MOO KYUN PARK1, JAE JUN SONG2, EUYHYUN PARK3, HOYUN LEE4, SUNGSU LEE5
¸ñÀû: Cognitive Behavioral Therapy (CBT) is an effective treatment for chronic tinnitus, but its traditional delivery is time-intensive, limiting its clinical use. To overcome this challenge, digital CBT programs customized for tinnitus patients are being developed. This study evaluated the effectiveness and safety of a new digital therapeutic program called Soundclear, a 6-week intervention combining personalized CBT with sound therapy, designed to reduce the mental and physical burden of subjective tinnitus. ¹æ¹ý:The study was a prospective, multicenter, randomized, single-blind trial conducted from November 2023 to June 2024 across five major medical centers. Adults aged 19 and older with tinnitus lasting more than three months and Tinnitus Handicap Inventory (THI) scores between 18 and 77 were included. Participants were divided into two groups: The experimental group used Soundclear, which included video lessons to challenge unhelpful thoughts about tinnitus, notch-filtered sound therapy, and a thought diary. The program involved 30 sessions (five sessions per week for six weeks). The control group received conventional CBT materials. A total of 112 participants were enrolled, and 105 completed the clinical trial At the end of six weeks, the Soundclear group showed significant improvement in THI scores compared to the control group, indicating better tinnitus-related mental and physical well-being. °á°ú:Improvements were also observed in emotional, functional, and catastrophic subscale scores, as well as secondary measures like the Tinnitus Functional Index (TFI) and Visual Analog Scale (VAS) for negative emotions and discomfort. Anxiety (Beck Anxiety Inventory, BAI) and depression (Beck Depression Inventory, BDI) scores also improved significantly. No serious adverse events were reported, confirming the safety of the program. °á·Ð:This study shows that a digital CBT program like Soundclear is a safe and effective treatment for chronic tinnitus. It holds great potential for integration into real-world clinical practice as a convenient therapeutic option.


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