[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652959":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":47,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":20,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot study","EXPERIMENTAL","Single-arm testing the feasibility of conducting a clinical trial testing three different home sleep apnea tests in patients with type 2 diabetes.",[13],"Device: Home Sleep Apnea Test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Home Sleep Apnea Test","Home sleep apnea testing with NightOwl, SleepImage and Nox T3",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mathilde Kjeldsen, MD, PhD student","CONTACT","+ 45 25 83 13 55","matkj@regionsjaelland.dk",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Preben Homøe, MD, PhD, DMSc","+ 45 47 32 96 09","prho@regionsjaelland.dk",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Dept of Otorhinolaryngology, ZUH Køge","RECRUITING","Køge","4600","Denmark","DK",{"type":40,"coordinates":41},"Point",[42,43],12.18214,55.45802,{"lat":43,"lon":42},[46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Preben Homøe","Professor",[52,54],{"name":53,"class":6},"The Novo Nordic Foundation",{"name":55,"class":56},"Steno Diabetes Center Sjaelland","OTHER_GOV","100652959","screening-for-obstructive-sleep-apnea-in-high-risk-patients-in-a-danish-rural-population-a-pilot-feasibility-study-100652959",false,"NCT07778121","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population","Inclusion Criteria:\n\n* Age 18 years or above\n* Diagnosed with type 2 diabetes mellitus\n* Resident in Region Zealand, Denmark\n* Understand and speak Danish\n\nExclusion Criteria:\n\n* Previously undergone surgery for OSA\n* Currently or within the last month used treatment for OSA such as CPAP, sleep position trainer, mandibular advancement devices etc.\n* Having an Implanted Cardioverter Defibrillator (ICD)\n* Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices",true,"ALL","18 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","Background:\n\nObstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis.\n\nDevices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate.\n\nThe study:\n\nThis study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main\u002Fdefinitive study.\n\nThe main study aims to assess the diagnostic agreement between the devices and will be registered independently.",[75,76],"Type 2 Diabetes","Obstructive Sleep Apnea (OSA)",[17,78,79,80,81,82,75,83,84,85,86,87,88,89],"HSAT","NightOwl","SleepImage","OSA","Obstructive Sleep Apnea","Peripheral Arterial Tonometry","Cardiopulmonary coupling","Screening","Feasibility","Pilot","Nox T3","Cardiorespiratory Monitor","2026-08-20",{"date":92,"type":93},"2026-08-21","ACTUAL",{"date":95,"type":93},"2025-10-20",{"date":97,"type":69},"2026-10-01",{"name":5,"class":6},1]