[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587281":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":63,"collaborators":66,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Universita di Verona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Digital Health Technology for Chronic Insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Treatment as Usual (TAU)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Elena Antelmi, Professor - Neurology","CONTACT","+393293526335","elena.antelmi@univr.it",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Giacomo Carollo, MSc - Psychology","+393454361133","giacomo.carollo@univr.it",[42],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Ospedale Borgo Roma - Neurologia B","RECRUITING","Verona","37129","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],10.9938,45.43854,{"lat":53,"lon":52},[56,58,59,61],{"name":33,"role":34,"phone":57,"phoneExt":26,"email":36},"3293526335",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"name":33,"role":60,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":38,"role":62,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":60,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Elena Antelmi","Associate Professor of Neurology and Clinical Neurologist",[67,70,72,74],{"name":68,"class":69},"Santer Reply S.p.A. Milan, Italy","UNKNOWN",{"name":71,"class":69},"daVi Digital Medicine s.r.l. Verona, Italy",{"name":73,"class":69},"QStep s.r.l. Verona, Italy",{"name":75,"class":69},"Fondazione RIDE2Med, Milan, Italy","100587281","assessment-of-usability-and-preliminary-effectiveness-of-a-digital-sleep-aid-in-an-italian-sample-100587281",false,"NCT06926348","Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample","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","REST","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Diagnosis of chronic insomnia according to DSM-5 criteria\n* Willingness to participate in the study and provide informed consent\n* Personal active email address\n* Ownership of a compatible mobile device with internet access (for the DHT group)\n\nExclusion Criteria:\n\n* Medical conditions requiring hospital admission during the study period\n* Comorbid diagnosis of sleep-related breathing disorders\n* Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)\n* Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months\n* Incompatible smartphone or lack of internet access (for DHT group)","ALL","18 Years","70 Years",{"count":88,"type":89},50,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.",[95,96],"Insomnia Chronic","Insomnia",[96,98,99,100,101],"CBT-i","Cognitive Behavioral Therapy for Insomnia","Digital Health Technology","DTx","2025-04-13",{"date":104,"type":105},"2025-04-17","ACTUAL",{"date":107,"type":105},"2025-03-10",{"date":109,"type":89},"2026-03-10",{"name":5,"class":6},1]