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Brain and Heart Rhythm Responses to a Breathing-Linked Sound Application (BELL-001) in Adults With Insomnia Symptoms
Sponsor: BELL Therapeutics Inc.
Summary
The purpose of this study was to describe how brain activity and heart rhythm respond to BELL-001, a smartphone application that plays sounds linked to the user's own breathing, compared with a sham application that looks the same but does not link its sounds to breathing. Adults with self-reported insomnia symptoms were randomly assigned to BELL-001 or to the sham application. During one laboratory visit, brain activity was recorded with electroencephalography (EEG), heart activity with electrocardiography (ECG), and breathing with a chest belt while participants rested with their eyes closed, then used the assigned application actively for 10 minutes, and then listened passively for 50 minutes. Participants then used the assigned application at home for 7 days while wearing a smartwatch.
Official title: Acute Neurophysiological and Autonomic Responses to a Respiratory-Coupled Sound-Based Digital Therapeutic (BELL-001) Versus Sham, Followed by 7 Days of Home Use, in Adults With Insomnia Symptoms: A Randomized, Sham-Controlled Study
Key Details
Gender
All
Age Range
19 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2025-11-18
Completion Date
2026-02-18
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
BELL-001 Digital Therapeutic
Smartphone-based digital therapeutic that plays sound linked to the user's breathing phase through insert earphones. In this study, the participant's own touchscreen press (inhalation) and release (exhalation) served as the breathing-phase signal during the active stage, followed by a sound sequence that slowed from the breathing rate established in the active stage. A respiration belt was used for recording only and was not an input to the application.
Sham Digital Therapeutic
Application with the same appearance and screen flow as BELL-001 that plays a single fixed pre-recorded sound not linked to breathing, with brief tones at random intervals during the active stage to match the touch task.
Locations (1)
Korea Institute of Science and Technology
Seoul, South Korea