Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia (NCT07295431) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia
South Korea114 participantsStarted 2026-01-15
Plain-language summary
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.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 19 to 75 years.
* Clinical diagnosis of insomnia disorder according to ICD-11 criteria (non-organic insomnia or sleep initiation/maintenance disorder).
* Insomnia Severity Index (ISI) score ≥ 15 at screening.
* Reports difficulty initiating or maintaining sleep at least 3 nights per week for ≥ 3 months.
* Willing and able to use a smartphone-based digital therapeutic during the pre-sleep period for 4 weeks.
* Able to provide informed consent and comply with study procedures.
Exclusion Criteria:
* Other primary sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).
* Major psychiatric disorders that may interfere with study assessment (e.g., psychotic disorders, bipolar disorder, severe major depressive episode).
* Substance use disorder, including alcohol or hypnotic misuse, within the past 12 months.
* Use of sleep-inducing medications or CNS-active drugs that cannot be stabilized or discontinued per protocol.
* Significant medical or neurological conditions that may affect sleep or study outcomes (e.g., severe cardiovascular, respiratory, or neurological disease).
* Night-shift workers or individuals with irregular sleep-wake schedules.
* Pregnancy or breastfeeding.
* Participation in another interventional clinical study within the past 30 days.
* Any condition judged by the investigator to interfere with study participation, safety, or data validity.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.