Digital therapy BELL-001 to help 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
Run by BELL Therapeutics Inc. · NCT07582809 · Data updated 2026-11-12
A smartphone-based therapy called BELL-001 is being tried in adults with insomnia to see if it is safe and helps people fall asleep and stay asleep over about 3 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | BELL Therapeutics Inc. Industry-sponsored |
| Locations | 3 sites (Incheon and 2 other locations) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07582809 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–75 with ICD-10 insomnia diagnoses, ISI ≥ 15, able to use a smartphone/tablet with internet, and willing to use BELL-001 as sole insomnia intervention besides CBT-I during the trial.
✕Probably not a fit
Patients who do not respond to the breathing-guided auditory therapy or have contraindicating factors may not experience sleep benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single-arm study to observe the long-term safety and effectiveness of the BELL-001 digital therapeutic device in adults with insomnia. BELL-001 uses personalized auditory feedback linked to a person’s breathing to promote relaxation before sleep. Participants use the smartphone-based therapy for about 12 weeks and are monitored for safety and sleep outcomes. The trial does not include a concurrent control group, but it aims to collect data on sleep initiation, maintenance, and daytime functioning alongside safety. Eligible participants are adults 19–75 with ICD-10 insomnia diagnoses and a baseline insomnia severity that meets the ISI threshold.
Why it matters
Potential benefit: If successful, participants may experience improved sleep onset and maintenance and better daytime function through a non-pharmacological, accessible digital therapy.
How similar studies have gone: Prior digital therapeutic approaches for insomnia have shown feasibility and potential benefit in some studies, but this exact smartphone-based, breathing-synchronised audio therapy is novel in this program.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where it's running
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Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea Recruiting -
CHA Bundang Hospital
Seongnam-si, South Korea Recruiting -
Seoul National University Hospital, Seoul, 03080
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Ki-Young Jung — Seoul National University Hospital
- Study coordinator: Jae-Eun Lee
- Email: jay.lee@belltherapeutics.com
- Phone: +82-70-8095-4983
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nurse-guided app-based brief behavioral therapy for insomnia in older adults
Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.