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

RecruitingNAAges 18 Years - 70 YearsAllUniversita di Verona
NCT06926348 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Digital Health Technology for Chronic Insomnia
  • Treatment as Usual (TAU)
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Where

1 site
Ospedale Borgo Roma - Neurologia B
Verona, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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