U.S., April 10 -- ClinicalTrials.gov registry received information related to the study (NCT07521319) titled 'Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)' on March 23.
Brief Summary: This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) ...