Last reviewed · How we verify
NCT06926348: REST
Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample
NA trial testing Digital Health Technology for Chronic Insomnia in Insomnia Chronic in 50 participants. Currently enrolling.
1 October 2025
Quick facts
| Lead sponsor | Universita di Verona |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 10 March 2025 |
| Primary completion | 1 October 2025 |
| Estimated completion | 10 March 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Digital Health Technology for Chronic Insomnia
- Treatment as Usual (TAU) — full drug profile →
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Insomnia — all drugs for Insomnia →
Sponsor
Universita di Verona — full company profile →
Who can join
Adults 18 to 70, any sex, with Insomnia Chronic or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06926348
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia Chronic
Currently open trials in the same condition.
- NCT07387406 — Sleep Learning Education and Empowerment for Older Korean Immigrants · NA · recruiting
- NCT07089797 — Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers · NA · recruiting
- NCT06736548 — Sleep Treatment Education Program for Cancer Survivors: STEP-Together · NA · recruiting
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
- NCT06827626 — Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care · NA · active not recruiting
Other Universita di Verona trials
Trials by the same sponsor.
- NCT07393919 — Discontination of Antidepressants in Remitted Depression · Phase 4 · not yet recruiting
- NCT07042724 — Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study · NA · recruiting
- NCT07129954 — Fear of Falling in Muscular Dystrophy · NA · recruiting
- NCT07119827 — Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury · recruiting
- NCT07209306 — WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06926348 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universita di Verona
- Last refreshed: 17 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06926348.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing