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Brain and Heart Rhythm Responses to a Breathing-Linked Sound Application (BELL-001) in Adults With Insomnia Symptoms

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

Sponsor
BELL Therapeutics Inc. (Industry)
Enrolment
72 enrolled
Conditions
Insomnia
Interventions
BELL-001 Digital Therapeutic; Sham Digital Therapeutic
Ages
adults
Registry
NCT07872007

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change in Sensor-Level Electroencephalography (EEG) Power in the Delta Band (0.1 to 4 Hz) From Rest to the Active and Passive Stages
  • Change in Sensor-Level Electroencephalography (EEG) Power in the Theta Band (4 to 8 Hz) From Rest to the Active and Passive Stages
  • Change in Sensor-Level Electroencephalography (EEG) Power in the Alpha Band (8 to 12 Hz) From Rest to the Active and Passive Stages
  • Change in Sensor-Level Electroencephalography (EEG) Power in the Low Alpha Band (8 to 10 Hz) From Rest to the Active and Passive Stages

History

  1. Registered

  2. Study completion

  3. Primary completion

  4. Started