Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample

Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources within the Italian healthcare system. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of a mobile application designed to assist individuals with chronic insomnia. The app offers digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot to promote healthy sleep behaviors. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either the intervention group, which will use the mobile application alongside their usual treatment, or to a control group receiving only standard care. The primary outcomes will assess the app's usability and participants' adherence to sleep hygiene practices. Secondary outcomes will evaluate changes in insomnia severity, mood, and quality of life. Assessments will occur at the start of the study, after the 8-week intervention, and at a 6-month follow-up to explore the intervention's long-term effects.

NCT Number	NCT06926348
Lead Sponsor	Universita di Verona Collaborators: Santer Reply S.p.A. Milan, Italy, daVi Digital Medicine s.r.l. Verona, Italy, QStep s.r.l. Verona, Italy, Fondazione RIDE2Med, Milan, Italy
Conditions	Insomnia Chronic, Insomnia
Enrollment	50 participants
Start Date	2025-03-10
Primary Completion	2025-10-01 (estimated)
Study Completion	2026-03-10 (estimated)
Updated on ClinicalTrials.gov	2025-04-17