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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Insomnia Chronic
• Intervention / Treatment: Behavioral: Digital Health Technology for Chronic Insomnia; Behavioral: Treatment as Usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Antelmi, Professor - Neurology; Phone Number: +393293526335; Email: elena.antelmi@univr.it
• Study Contact Backup: Name: Giacomo Carollo, MSc - Psychology; Phone Number: +393454361133; Email: giacomo.carollo@univr.it

Study Locations

• Italy
  • Verona, Italy, 37129
    • Recruiting
    • Ospedale Borgo Roma - Neurologia B
    • Contact: Giacomo Carollo, MSc - Psychology; Phone Number: +393454361133; Email: giacomo.carollo@univr.it
    • Contact: Elena Antelmi, Professor - Neurology; Phone Number: 3293526335; Email: elena.antelmi@univr.it
    • Contact: Elena Antelmi, Professor - Neurology
    • Contact: Giacomo Carollo, MSc - Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and Acceptability of Digital Health Technology (DHT)	Usability and acceptability measured by the User Experience Questionnaire (UEQ) and digital engagement metrics, including app access frequency, session duration, notification interactions, and drop-out rates.	After 8 weeks of intervention (T1)
Adherence to Sleep Hygiene Practices	Change in adherence to recommended sleep hygiene behaviors assessed through the Sleep Hygiene Index (SHI).	Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	Change in insomnia severity measured using the Insomnia Severity Index, evaluating subjective sleep disturbance and related daytime impairment.	Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
Mood and Emotional Distress	Change in anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS).	Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
Health-Related Quality of Life	Change in quality of life across multiple dimensions (e.g., physical functioning, emotional wellbeing) assessed using the Short Form Health Survey (SF-12).	Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: Santer Reply S.p.A. Milan, Italy; daVi Digital Medicine s.r.l. Verona, Italy; QStep s.r.l. Verona, Italy; Fondazione RIDE2Med, Milan, Italy

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): March 10, 2026

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Cognitive Behavioral Therapy for Insomnia; CBT-i; Digital Health Technology; DTx
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 413CET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) collected in this study will not be shared due to institutional data protection policies and GDPR compliance. Given the sensitivity of health-related personal data and the nature of the digital tools involved, sharing IPD externally poses potential privacy and security risks that cannot be sufficiently mitigated. Additionally, participants were informed that their data would only be accessible to authorized personnel directly involved in the research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No