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

NCT07582809 | Not Yet Recruiting

• 1 other identifier: BELL-001-S-KR-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Insomnia; Sleep Initiation and Maintenance Disorders

Keywords

BELL-001; Digital Therapeutics; Insomnia Treatment; Auditory stimulation; Biofeedback; Autonomic Regulation; Breathing-Synchronized Therapy

Outcome Measures

Primary Outcomes (1)

• Safety data from 12 weeks of BELL-001 use

  All adverse events and device deficiencies occurring during this clinical trial

  From enrollment to end of treatment at 12 weeks

Secondary Outcomes (15)

• Change in Insomnia Severity Index (ISI) Score

  From baseline to Weeks 4, 8, and 12

• Change in Depressive Symptoms (PHQ-9)

  Baseline to 4,8 and 12 weeks

• Change in Anxiety Symptoms (GAD-7)

  Baseline to Week 4,8 and 12

• Change in Work Productivity and Activity Impairment (WPAI-GH)

  Baseline to Week 4, 8 and 12

• Changes in Nearable Device Sleep Parameter

  Baseline to Weeks 4, 8, and 12

Other Outcomes (2)

• User Response Assessment (compliance and satisfaction with usability)

  From enrollment to end of treatment at 12 weeks

• Respiratory acoustic data collected via smartphone microphone

  From enrollment to end of treatment at 12 weeks

Study Arms (1)

BELL-001 Digital Therapeutic

EXPERIMENTAL

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. The intervention is administered nightly during the pre-sleep period for 12 weeks. The device delivers an active algorithm intended to reduce pre-sleep hyperarousal and support sleep initiation

Device: BELL-001 Digital Therapeutic

Interventions

BELL-001 Digital Therapeutic DEVICE

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.

BELL-001 Digital Therapeutic

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BELL Therapeutics Inc.: lead

Study Sites (3)

Catholic Kwandong University International St. Mary's Hospital

Incheon, South Korea

Location

CHA Bundang Hospital

Seongnam-si, South Korea

Location

Seoul National University Hospital, Seoul, 03080

Seoul, South Korea

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ki-Young Jung

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Hye-Yoon Kim

  Catholic Kwandong University International St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Jung-Won Shin

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Eun Lee

CONTACT

+82-70-8095-4983; jay.lee@belltherapeutics.com

Hye-won Lee

CONTACT

+82-70-8095-4983; hyewon.lee@belltherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

KR (3)