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

NCT06926348 | Recruiting

• 1 other identifier: 413CET
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Insomnia

Keywords

Insomnia; CBT-i; Cognitive Behavioral Therapy for Insomnia; Digital Health Technology; DTx

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Insomnia Severity Index (ISI)

  Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

• Mood and Emotional Distress

  Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

• Health-Related Quality of Life

  Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

Study Arms (2)

Digital Health Technology (DHT) + Treatment As Usual (TAU)

EXPERIMENTAL

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

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Digital Health Technology for Chronic Insomnia BEHAVIORAL

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

Digital Health Technology (DHT) + Treatment As Usual (TAU)

Treatment as Usual (TAU) BEHAVIORAL

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.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Ospedale Borgo Roma - Neurologia B

Verona, Verona, 37129, Italy

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Digital Health; Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Elena Antelmi, Professor - Neurology

CONTACT

+393293526335; elena.antelmi@univr.it

Giacomo Carollo, MSc - Psychology

CONTACT

+393454361133; giacomo.carollo@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology and Clinical Neurologist

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: March 10, 2025
• Primary Completion: October 1, 2025
• Study Completion: March 10, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)