[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435373":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":50,"locations":58,"responsibleParty":78,"collaborators":36,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":36,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":36,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":61,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"SleepUp Tecnologia em Saúde Ltda","INDUSTRY",[8,14,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard CBTi (CBTi-S):","ACTIVE_COMPARATOR","This is a positive control group\u002Factive comparator, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structured appointments with a board-certified sleep psychologist. The professionals performing the CBTi sessions will not be part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.",[13],"Behavioral: Regular Cognitive Behavioural Therapy for Insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"Minimal intervention - Sleep hygiene (MI-SH):","PLACEBO_COMPARATOR","This group corresponds to a negative control group\u002Fplacebo comparator, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no-treatment or waiting list controls, due to the behavioral nature of insomnia.",[19],"Behavioral: Sleep hygiene - minimal intervention",{"label":21,"type":22,"description":23,"interventionNames":24},"Online CBTI (CBTI-O)","EXPERIMENTAL","This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track will be removed. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.",[25],"Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies",{"label":27,"type":22,"description":28,"interventionNames":29},"Online CBTi + additional features (CBTi-O+)","This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.",[25],[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies","The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.",[21,27],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Regular Cognitive Behavioural Therapy for Insomnia","This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.",[9],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Sleep hygiene - minimal intervention","It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app.",[15],[46],{"name":47,"affiliation":48,"role":49},"Gabriel N. Pires, PhD","Universidade Federal de São Paulo","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":36,"email":55},"Pesquisa SleepUp","CONTACT","+55 11 93319-1375","pesquisa@sleepup.com.br",{"name":47,"role":53,"phone":57,"phoneExt":36,"email":55},"+55 11 933191375",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"SleepUp Tecnologia em Saúde LTDA","RECRUITING","São Caetano do Sul","São Paulo","09530-250","Brazil","BR",{"type":68,"coordinates":69},"Point",[70,71],-46.55111,-23.62306,{"lat":71,"lon":70},[74],{"name":75,"role":53,"phone":76,"phoneExt":36,"email":77},"Renata Bonaldi, PhD","+55 11 95555-6467","renata.bonaldi@sleepup.com.br",{"type":79,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100435373","sleepup-digital-cbti-based-platform-for-insomnia-100435373",false,"NCT04949360","SleepUp Digital CBTi-based Platform for Insomnia","Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia","Inclusion Criteria:\n\n* Literate Brazilian portuguese speakers.\n* Insomnia symptoms (as measured by ISI).\n* An Android-based smartphone or tablet with access to the Internet.\n\nExclusion Criteria:\n\n* Previous experience with CBTi.\n* Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.","ALL","20 Years","60 Years",{"count":91,"type":92},280,"ESTIMATED","INTERVENTIONAL",[95],"NA","Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases.\n\nPhase 1\n\nThe sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups:\n\n* Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists).\n* Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral\n* Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.\n* Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.\n\nAll participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.\n\nPhase 2\n\nThis phase will comprise 120 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in three groups:\n\n* Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral\n* Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.\n* Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.\n\nAll participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.",[98,99,100],"Insomnia","Sleep Disorder","Sleep Hygiene",[98,102,103,104],"Sleep","Cognitive-behavioral therapy","CBTi","2025-12-20",{"date":107,"type":108},"2025-12-29","ACTUAL",{"date":110,"type":108},"2025-05-19",{"date":112,"type":92},"2026-12-01",{"name":5,"class":6},1]