Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia

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

Interventions

DEVICE

BELL-001 Digital Therapeutic

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.

DEVICE

Sham Digital Therapeutic

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.

Sponsors & Collaborators

• BELL Therapeutics Inc.

  lead INDUSTRY

Principal Investigators

• Ki-Young Jung · Seoul National University Hospital

• Jung-ik Byun · Kyung Hee University Hospital at Gangdong

• Joon-Sang Sunwoo · Kangbuk Samsung Hospital

• Kyung-Jin Hwang · Kyunghee University Medical Center

• Jung-Won Shin · CHA Bundang Medical Center

• Hye-Yoon Kim · Catholic Kwandong University International St. Mary's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2026-05-31

Completion

2026-07-31

Countries

• South Korea

Study Locations