[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552614":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":37,"locations":31,"responsibleParty":43,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":31,"enrollmentInfo":57,"targetDuration":31,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":31,"overallStatus":66,"whyStopped":31,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":31},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I","ACTIVE_COMPARATOR","Cognitive Behavioral Therapy for Insomnia (CBT-I) will be provided and seen as 'no intervention'",[13],"Behavioral: Cognitive Behavioral Therapy for Insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"CBT-I + Moonbird (MB)","EXPERIMENTAL","Cognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a technology supported breathing exercises with a tactile breath pacer device (Moonbird)",[19,13],"Device: Moonbird",{"label":21,"type":22,"description":23,"interventionNames":24},"CBT-I + MBsham","SHAM_COMPARATOR","Cognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a non-functioning technology supported breathing exercises with a tactile breath pacer device (Moonbird)",[13],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Moonbird","Moondbird is a technology-supported breathing exercise with a tactile breath pacer device",[15],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"BEHAVIORAL","Cognitive Behavioral Therapy for Insomnia","Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia, as it is proven to be highly effective in improving sleep quality. It is a multifaceted approach, which includes time-in-bed restriction (i.e., reducing time spent in bed to enhance sleep consolidation), stimulus control (i.e., restricting behaviours incompatible with sleep in the bedroom), and cognitive restructuring (i.e., addressing and altering maladaptive thoughts and beliefs regarding sleep) to reinstate a regular sleep pattern.",[9,21,15],[38],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Zosia Goossens","CONTACT","02 629 25 26","zosia.goossens@vub.be",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Olivier Mairesse","Prof","100552614","enhancing-sleep-onset-the-power-of-tactile-breath-pacer-in-cognitive-behavioral-therapy-for-insomnia-100552614",false,"NCT06475378","Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia","MOONBIRD","Inclusion Criteria:\n\n* Patients must be diagnosed with chronic insomnia.\n\nExclusion Criteria:\n\n* Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.",true,"ALL","18 Years",{"count":58,"type":59},72,"ESTIMATED","INTERVENTIONAL",[62],"NA","The purpose of the study is to evaluate the effectiveness of technology-assisted breathing exercises combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) in primary insomnia patients to investigate. For this purpose, we will conduct 1 study. This will be a randomized controlled trial in which 72 patients randomly and stratified by gender will be divided into 3 groups. A first group follows the standard treatment Cognitive Behavioral Therapy for Insomnia (CBT-I), the second group follows the combined treatment Cognitive Behavioral Therapy for Insomnia with a technology supported breathing exercises with a tactile breath pacer device (Moonbird) (CBT-I + Moonbird) and a third group follows the standard treatment Cognitive Behavioral Therapy for Insomnia and receives a non-functional technology supported breathing exercises with a tactile breath pacer device (Moonbird). The therapy, baseline measurements, screening for inclusion and questionnaire administration and ambulatory polysomnography (PSG) will be performed by the sleep psychologists at the UZ Brussel. The polysomnography screening for in- or exclusion (i.e. presence of other untreated sleep disorders) will be performed at the UZ Brussel. Furthermore, two follow-up measurements will be scheduled. The first measurement will take place immediately after the treatment while the second measurement will take place 3 months after the treatment.",[65],"Primary Insomnia","NOT_YET_RECRUITING","2025-02-13",{"date":69,"type":70},"2025-02-18","ACTUAL",{"date":72,"type":59},"2025-03-01",{"date":74,"type":59},"2026-09-01",{"name":5,"class":6}]