Clinical trials

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.

This study is a multicenter, randomized, double-blind, sham-controlled clinical investigation designed to evaluate the effectiveness and safety of BELL-001, a digital therapeutic developed to improve symptoms of insomnia. Insomnia is a common sleep disorder that can significantly affect daytime functioning, mood, and overall quality of life. Many patients continue to have difficulties despite lifestyle changes or medication, and safer, non-pharmacological treatment options are increasingly needed. BELL-001 is a smartphone-based therapeutic that delivers personalized auditory stimulation during the pre-sleep period. The device is intended to promote relaxation and support the transition into sleep by analyzing individual breathing patterns and providing synchronized sound feedback. The study will compare BELL-001 with a sham (placebo-like) digital device that looks identical but does not provide the active therapeutic functions. Adults diagnosed with insomnia will be randomly assigned to either the BELL-001 group or the sham group. Participants will use the assigned device for four weeks. Throughout the study, sleep-related symptoms, daytime functioning, fatigue, and quality-of-life measures will be assessed. The primary outcome is the change in Insomnia Severity Index (ISI) scores after four weeks of treatment. Safety will be monitored regularly through participant reports and clinical evaluations. This trial is being conducted at multiple hospitals in Korea and follows ethical guidelines, including review and approval by institutional review boards (IRBs). Participation is voluntary, and all individuals will provide informed consent before any study procedures begin. The results of this study are expected to provide key evidence for the clinical use of a digital, non-pharmacological intervention for adults with insomnia.