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

Recruiting now · Not applicable

Conditions studied: Insomnia Chronic, Insomnia

In brief

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.

Key facts

Study ID

NCT06926348

Run by

Universita di Verona

People needed

50

Starts

2025-03-10

Expected to finish

2026-03-10

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Ospedale Borgo Roma - Neurologia B — Verona, Verona, Italy (enrolling)

Full record on ClinicalTrials.gov

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