Evaluating a mobile app for chronic insomnia treatment in Italy
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
This study tests whether a mobile app can help adults with chronic insomnia improve their sleep when used alongside their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 1 site (Verona, Verona) |
| Trial ID | NCT06926348 on ClinicalTrials.gov |
What this trial studies
This pilot trial assesses the usability and preliminary effectiveness of a mobile application designed to help individuals with chronic insomnia. The app includes features such as digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either use the app alongside their usual treatment or receive standard care only. The study aims to determine how well the app can support users in managing their sleep issues over an 8-week period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 years who have been diagnosed with chronic insomnia.
Not a fit: Patients with comorbid sleep-related breathing disorders or those currently receiving psychological treatment for insomnia may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could provide a scalable and accessible solution for managing chronic insomnia, improving patients' sleep quality and overall health.
How similar studies have performed: Other studies have shown promise in using digital health technologies for insomnia management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Verona, Verona
- Ospedale Borgo Roma - Neurologia B — Verona, Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Antelmi, Professor - Neurology
- Email: elena.antelmi@univr.it
- Phone: +393293526335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.