Status:
RECRUITING
Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample
Lead Sponsor:
Universita di Verona
Collaborating Sponsors:
Santer Reply S.p.A. Milan, Italy
daVi Digital Medicine s.r.l. Verona, Italy
Conditions:
Insomnia Chronic
Insomnia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Detailed Description
This randomized controlled pilot trial evaluates a Digital Health Technology (DHT) developed as a Health \& Wellness tool aimed at supporting individuals diagnosed with chronic insomnia. Chronic insom...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Medical conditions requiring hospital admission during the study period
- Comorbid diagnosis of sleep-related breathing disorders
- Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)
- Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months
- Incompatible smartphone or lack of internet access (for DHT group)
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06926348
Start Date
March 10 2025
End Date
March 10 2026
Last Update
April 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Borgo Roma - Neurologia B
Verona, Verona, Italy, 37129