Clinical trial NCT06926348: Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Insomnia
Keywords: Insomnia
CBT-i
Cognitive Behavioral Therapy for Insomnia
Digital Health Technology
DTx
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Santer Reply S.p.A. Milan, Italy
name: daVi Digital Medicine s.r.l. Verona, Italy
name: QStep s.r.l. Verona, Italy
name: Fondazione RIDE2Med, Milan, Italy
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Usability and Acceptability of Digital Health Technology (DHT)
timeFrame: After 8 weeks of intervention (T1)
measure: Adherence to Sleep Hygiene Practices
timeFrame: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
measure: Mood and Emotional Distress
timeFrame: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
measure: Health-Related Quality of Life
timeFrame: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Ospedale Borgo Roma - Neurologia B
Study officials:
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