Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia

NCT07295431 | Not Yet Recruiting

• 1 other identifier: BELL-001-S-KR-003
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Insomnia; Sleep Initiation and Maintenance Disorders

Keywords

Digital Therapeutic; BELL-001; Insomnia Treatment; Auditory stimulation; Biofeedback; Sleep Onset Latency; Sham-Controlled Trial; Autonomic Regulation; Breathing-Synchronized Therapy

Outcome Measures

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.

  Baseline to Week 4

Secondary Outcomes (8)

• Change in Daytime Sleepiness (Epworth Sleepiness Scale, ESS)

  Baseline to Week 4

• Change in Fatigue Severity (Fatigue Severity Scale, FSS)

  Baseline to Week 4

• Change in Depressive Symptoms (PHQ-9)

  Baseline to 4 weeks

• Change in Anxiety Symptoms (GAD-7)

  Baseline to Week 4

• Change in Health-Related Quality of Life (EQ-5D-5L)

  Baseline to 4 weeks

Other Outcomes (1)

• Responder Rate (≥6-point improvement in ISI)

  Baseline to Week 4

Study Arms (2)

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 4 weeks. The device delivers an active algorithm intended to reduce pre-sleep hyperarousal and support sleep initiation.

Device: BELL-001 Digital Therapeutic

Sham Digital Therapeutic

SHAM COMPARATOR

Participants assigned to the sham arm will use a visually identical digital device that does not deliver the active therapeutic algorithm. The sham device mimics the user interface and appearance of BELL-001 to maintain blinding but provides non-therapeutic audio output. Participants will use the device nightly during the pre-sleep period for 4 weeks.

Device: Sham 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 4 weeks. The active algorithm delivers respiratory-synchronized auditory feedback intended to reduce pre-sleep hyperarousal and support sleep initiation.

BELL-001 Digital Therapeutic

Sham Digital Therapeutic DEVICE

A 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.

Sham 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BELL Therapeutics Inc.: lead

Study Sites (6)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Catholic Kwandong University International St. Mary's Hospital

Seoul, South Korea

Location

CHA Bundang Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Kyung Hee University Medical Center

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

• Jung-ik Byun

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

• Joon-Sang Sunwoo

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Kyung-Jin Hwang

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Jung-Won Shin

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

• Hye-Yoon Kim

  Catholic Kwandong University International St. Mary's Hospital

  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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design. Participants, investigators, care providers, and outcome assessors are blinded to treatment assignment. The sham device is visually identical to the active device but does not deliver the therapeutic algorithm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, parallel-group, sham-controlled clinical investigation evaluating the efficacy and safety of the digital therapeutic BELL-001 in adults with insomnia.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

KR (6)