Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adults aged 18 to 70 years

• Diagnosis of chronic insomnia according to DSM-5 criteria

• Willingness to participate in the study and provide informed consent

• Personal active email address

• Ownership of a compatible mobile device with internet access (for the DHT group)

Locations
Other Locations
Italy
Ospedale Borgo Roma - Neurologia B
RECRUITING
Verona
Contact Information
Primary
Elena Antelmi, Professor - Neurology
elena.antelmi@univr.it
+393293526335
Backup
Giacomo Carollo, MSc - Psychology
giacomo.carollo@univr.it
+393454361133
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 50
Treatments
Experimental: Digital Health Technology (DHT) + Treatment As Usual (TAU)
Participants in this arm receive an 8-week intervention involving a mobile app designed for chronic insomnia management. The app includes digital sleep diaries, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and an interactive chatbot for enhanced engagement. This intervention complements standard treatment (TAU), which may include pharmacotherapy and routine clinical care.
Active_comparator: Treatment As Usual (TAU)
Participants assigned to this arm continue their usual insomnia management, including pharmacological treatments if prescribed, and receive standardized educational material on sleep hygiene practices via a printed booklet. They also maintain printed sleep diaries for self-monitoring throughout the 8-week study period.
Related Therapeutic Areas
Sponsors
Collaborators: QStep s.r.l. Verona, Italy, Fondazione RIDE2Med, Milan, Italy, daVi Digital Medicine s.r.l. Verona, Italy, Santer Reply S.p.A. Milan, Italy
Leads: Universita di Verona

This content was sourced from clinicaltrials.gov