Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorBELL Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BELL-001 Digital Therapeutic
DeviceParticipants 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 4 weeks. The active algorithm delivers respiratory-synchronized auditory feedback intended to reduce pre-sleep hyperarousal and support sleep initiation.
Sham Digital Therapeutic
DeviceA sham version of the BELL-001 software that is visually indistinguishable from the active device but lacks the respiratory-synchronized therapeutic algorithm. It provides non-synchronized audio output and serves as the control condition. Used nightly during the pre-sleep period for 4 weeks.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: BELL-001 Digital TherapeuticExperimental treatment 1 intervention
Group B: Sham Digital TherapeuticSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) Score
The primary endpoint is the change in the Insomnia Severity Index (ISI) total score from baseline to Week 4. The ISI is a validated 7-item patient-reported outcome measure assessing nighttime symptoms, sleep satisfaction, and the impact of insomnia on daytime functioning. Higher scores indicate more severe insomnia.
Time frame
Baseline to Week 4Secondary outcomes
1
Change in Daytime Sleepiness (Epworth Sleepiness Scale, ESS)
Change in ESS score evaluating daytime sleepiness. Higher scores reflect greater sleep propensity.
Time frame
Baseline to Week 42
Change in Fatigue Severity (Fatigue Severity Scale, FSS)
Change in FSS score assessing the impact of fatigue on daily functioning.
Time frame
Baseline to Week 43
Change in Depressive Symptoms (PHQ-9)
Change in PHQ-9 score to evaluate depressive symptom severity.
Time frame
Baseline to 4 weeks4
Change in Anxiety Symptoms (GAD-7)
Change in GAD-7 score reflecting the severity of generalized anxiety symptoms.
Time frame
Baseline to Week 4Other outcomes
1
Responder Rate (≥6-point improvement in ISI)
Proportion of participants achieving clinically meaningful ISI reduction
Time frame
Baseline to Week 4Sponsors and contacts
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Source ClinicalTrials.gov
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