Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversita di Verona
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Health Technology for Chronic Insomnia
BehavioralA 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)
BehavioralParticipants 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 groups
50 Participants
are divided into 2 treatment groupsGroup A: Digital Health Technology (DHT) + Treatment As Usual (TAU)Experimental treatment 1 intervention
Group B: Treatment As Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After 8 weeks of intervention (T1)2
Adherence to Sleep Hygiene Practices
Change in adherence to recommended sleep hygiene behaviors assessed through the Sleep Hygiene Index (SHI).
Time frame
Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)Secondary outcomes
1
Insomnia Severity Index (ISI)
Change in insomnia severity measured using the Insomnia Severity Index, evaluating subjective sleep disturbance and related daytime impairment.
Time frame
Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)2
Mood and Emotional Distress
Change in anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS).
Time frame
Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)3
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).
Time frame
Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universita di Verona
Lead sponsor
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
Source ClinicalTrials.gov