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

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 insomnia significantly impacts quality of life and poses a considerable burden on healthcare systems. Despite Cognitive Behavioral Therapy for Insomnia (CBT-I) being the recommended first-line treatment, its limited accessibility in Italy necessitates scalable and innovative solutions. The DHT under investigation is a mobile application developed collaboratively by the University of Verona and private-sector partners, designed specifically for educational purposes and the promotion of healthy sleep behaviors.

The intervention is structured over an 8-week period, during which participants are expected to engage daily with the application. The DHT includes several core functionalities:

Digital Sleep Diaries: Participants document their sleep habits daily, including sleep onset latency, total sleep duration, wake after sleep onset, and sleep efficiency. This self-monitoring aims to increase sleep-awareness and encourage consistent engagement with healthy sleep behaviors.

Personalized Educational Content: Users gain access to educational modules designed according to CBT-I principles. Topics include optimizing the sleep environment, maintaining consistent sleep schedules, managing lifestyle factors affecting sleep, and addressing common misconceptions about sleep.

Relaxation and Mindfulness Exercises: The app provides guided audio and video exercises focusing on relaxation techniques such as deep breathing and progressive muscle relaxation, alongside mindfulness practices intended to reduce pre-sleep arousal and facilitate better sleep.

Interactive Chatbot: An integrated conversational agent assists users in navigating app functionalities, provides personalized reminders, motivational feedback, and real-time assistance, enhancing user engagement and compliance.

Participants (N=50) are recruited from the outpatient clinic at Borgo Roma Hospital, Verona. Eligible individuals are randomly assigned in a 1:1 ratio to either receive the DHT intervention combined with Treatment as Usual (DHT + TAU), or Treatment as Usual (TAU) alone. TAU involves standardized educational materials on sleep hygiene practices provided via printed booklets and continued management under the patient's usual healthcare provider.

Assessments are conducted at baseline (T0), immediately post-intervention (T1), and at a 6-month follow-up (T2). Primary outcomes focus on usability and acceptability, measured by the User Experience Questionnaire (UEQ), digital engagement metrics, and adherence to sleep hygiene practices via the Sleep Hygiene Index (SHI). Secondary outcomes assess preliminary efficacy regarding insomnia severity (Insomnia Severity Index - ISI), mood disturbances (Hospital Anxiety and Depression Scale - HADS), and overall health-related quality of life (Short Form Health Survey - SF-12).

Data collection employs the secure LimeSurvey platform to ensure participant confidentiality and data protection according to GDPR standards. Data analysis includes Linear Mixed Effects Models, exploratory analyses for identifying predictors of treatment response, and sensitivity analyses for assessing robustness of findings.

This feasibility trial aims to inform future large-scale studies by evaluating the potential benefits and limitations of using a scalable, non-medical DHT in the routine management of chronic insomnia. Results are anticipated to contribute substantially to the evidence base supporting digital interventions as viable adjuncts to standard care for insomnia.

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)