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NCT07582809

Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia

Sponsor: BELL Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06

Completion Date

2026-12

Last Updated

2026-05-13

Healthy Volunteers

Conditions

Insomnia Sleep Initiation and Maintenance Disorders

Interventions

DEVICE

BELL-001 Digital Therapeutic

Participants assigned to the experimental arm will use BELL-001, a smartphone-based digital therapeutic designed to provide personalized auditory stimulation synchronized with the user's breathing pattern. Participants will use the device nightly during the pre-sleep period for 12 weeks. The active algorithm delivers respiratory-synchronized auditory feedback intended to reduce pre-sleep hyperarousal and support sleep initiation.

Inclusion Criteria: * Diagnosed with ICD-11 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 Exclusion Criteria: * Individuals with severe psychiatric disorders, including major depressive disorder * Individuals diagnosed with or suspected of having insomnia comorbid with narcolepsy (G47.4), obstructive sleep apnea (G47.30), restless legs syndrome (G25.81), periodic limb movement disorder (G47.61), or REM sleep behavior disorder (G47.52) per ICD-10-CM codes * Individuals with active physical illness or unstable medical conditions that interfere with activities of daily living, including congestive heart failure, chronic obstructive pulmonary disease (COPD), acute pain, cerebrovascular disease (e.g., stroke), or neurodegenerative disorders (e.g., dementia, multiple sclerosis) * Individuals whose insomnia symptoms are considered to be caused or exacerbated by the physiological effects of medications (prescription drugs or substances of abuse) or alcohol * Individuals deemed by the investigator to be unable to participate in the study due to respiratory conditions such as asthma * Individuals with moderate or greater hearing loss in both ears * Individuals suspected of sleep medication dependence at the investigator's discretion * Individuals with a history of change in the type or dosage of sleep medications, antidepressants, anticonvulsants, anxiolytics, or antipsychotics within 4 weeks prior to the baseline visit (Visit 2) * Individuals currently reporting persistent tinnitus symptoms * Individuals diagnosed with shift work sleep-wake disorder, or those who experience periodic insomnia or sleep-wake rhythm disturbance due to a work environment requiring repeated circadian readjustment, such as day/night shift rotation or frequent international travel * Individuals who took PRN (as-needed) sleep medications during the screening period (including the day before Visit 1) * Individuals who used other investigational drugs or investigational digital medical devices within 3 months prior to Visit 1 I-ndividuals with prior experience using BELL-001 * Individuals deemed inappropriate for participation in the clinical trial by the investigator for any other reason

Locations (3)

Catholic Kwandong University International St. Mary's Hospital

Incheon, South Korea

CHA Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital, Seoul, 03080

Seoul, South Korea