A Multicenter, Single-arm, Prospective Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia
This study is a multicenter, single-arm, prospective clinical trial designed to observe the long-term safety and effectiveness of the digital medical device BELL-001 in patients diagnosed with insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to experience difficulties despite lifestyle modifications or pharmacological treatment, and there is a growing need for safer, non-pharmacological therapeutic options. BELL-001 is a smartphone-based therapeutic device that delivers personalized auditory stimulation during the pre-sleep period. The device is designed to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. This study evaluates the long-term safety and effectiveness of BELL-001 over approximately 3 months (12 weeks) of use. Forty adults diagnosed with insomnia will participate as the BELL-001 group. Participants will use the device for 12 weeks. During the study period, insomnia severity, depression, anxiety, and work productivity will be assessed. The outcome measures include changes in the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Work Productivity and Activity Impairment Questionnaire (WPAI) at 4, 8, and 12 weeks compared to baseline; changes in Total Sleep Time (TST), Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), and sleep stage ratios measured via Nearable Device at 4, 8, and 12 weeks; and changes in subjective Sleep Latency (sSL), subjective Sleep Quality (sSQ), subjective Wake After Sleep Onset (sWASO), subjective number of awakenings after sleep onset, subjective Sleep Efficiency (sSE), and subjective Total Sleep Time (sTST) assessed through sleep diaries at 4, 8, and 12 weeks compared to baseline. Safety will be evaluated over the 12-week period. Additional outcome measures will include assessment of compliance and satisfaction. This clinical trial is conducted at multiple hospitals in Korea and adheres to ethical guidelines, including review and approval by Institutional Review Boards (IRBs). Participation is voluntary, and all individuals will provide informed consent prior to the initiation of any study procedures. The results of this study are expected to provide key evidence for the clinical application of a digital, non-pharmacological intervention for adults with insomnia.
• Diagnosed with ICD-10 nonorganic insomnia (F51.0) or sleep initiation and maintenance disorder (insomnia, G47.0)
• Insomnia Severity Index (ISI) score ≥ 15
• Adults aged 19 to 75 years
• Capable of using a smartphone or tablet and has access to a stable internet connection
• Willing to provide written informed consent voluntarily and able to comply with all study procedures
• Agrees not to initiate any other insomnia treatment other than cognitive behavioral therapy for insomnia during the trial
• Has completed sleep diary entries for at least 3 out of 7 days from the day after the screening visit through the day of the baseline visit (Visit 2)
• At the baseline visit (Visit 2), sleep diary data from the preceding 7 days confirms at least 3 nights with a sleep onset latency of 30 minutes or more, or wake after sleep onset of 60 minutes or more