Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample
NCT ID: NCT06926348
Last Updated: 2025-04-17
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-03-10
2026-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Digital Health Technology (DHT) + Treatment As Usual (TAU)
Participants in this arm receive an 8-week intervention involving a mobile app designed for chronic insomnia management. The app includes digital sleep diaries, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and an interactive chatbot for enhanced engagement. This intervention complements standard treatment (TAU), which may include pharmacotherapy and routine clinical care.
Digital Health Technology for Chronic Insomnia
A mobile application designed to support chronic insomnia management through digital self-monitoring of sleep patterns, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and chatbot interactions. Users receive tailored notifications and educational content to encourage healthy sleep behaviors over an 8-week period. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged
Treatment As Usual (TAU)
Participants assigned to this arm continue their usual insomnia management, including pharmacological treatments if prescribed, and receive standardized educational material on sleep hygiene practices via a printed booklet. They also maintain printed sleep diaries for self-monitoring throughout the 8-week study period.
Treatment as Usual (TAU)
Participants receive standard sleep hygiene recommendations via a printed educational booklet. They maintain printed sleep diaries for daily self-monitoring throughout the 8-week intervention. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged.
Interventions
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Digital Health Technology for Chronic Insomnia
A mobile application designed to support chronic insomnia management through digital self-monitoring of sleep patterns, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and chatbot interactions. Users receive tailored notifications and educational content to encourage healthy sleep behaviors over an 8-week period. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged
Treatment as Usual (TAU)
Participants receive standard sleep hygiene recommendations via a printed educational booklet. They maintain printed sleep diaries for daily self-monitoring throughout the 8-week intervention. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Santer Reply S.p.A. Milan, Italy
UNKNOWN
daVi Digital Medicine s.r.l. Verona, Italy
UNKNOWN
QStep s.r.l. Verona, Italy
UNKNOWN
Fondazione RIDE2Med, Milan, Italy
UNKNOWN
Universita di Verona
OTHER
Responsible Party
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Elena Antelmi
Associate Professor of Neurology and Clinical Neurologist
Locations
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Ospedale Borgo Roma - Neurologia B
Verona, Verona, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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413CET
Identifier Type: -
Identifier Source: org_study_id
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