[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559884":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sleepiz AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleepiz One+ vs. gold standard","OTHER","Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.",[13],"Device: Sleepiz One+",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Sleepiz One+","In this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 42 minutes.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Christian Neumann, Dr. med.","Zentrum für Schlafmedizin \"Schlaflabor Fluntern\"","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Marta Stepien, MSc","CONTACT","+41 44 586 08 88","marta.stepien@sleepiz.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Schlaflabor Fluntern","RECRUITING","Zurich","Canton of Zurich","8044","Switzerland","CH",{"type":42,"coordinates":43},"Point",[44,45],8.55,47.36667,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":20,"phoneExt":20,"email":20},"Christian Neumann, Dr. med,",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100559884","sleepiz-one-vs-capnography-and-electrocardiography-100559884",false,"NCT06569940","Sleepiz One+ vs. Capnography and Electrocardiography","Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard","Inclusion Criteria:\n\nPatients:\n\n* Age \\>=18years\n* Informed Consent as documented by signature\n* One (or more) chronic medical condition\u002Fs (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)\n\nHealthy volunteers\n\n* Age \\>=18years\n* Informed Consent as documented by signature\n* No diagnosed chronic medical condition\n\nExclusion Criteria:\n\nPatients\n\n* Previous enrolment into the current study,\n* Cardiac pacemaker or another implanted electrical device\n* Women who are pregnant or breastfeeding\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant\n\nHealthy volunteers:\n\n* Previous enrolment into the current study,\n* Cardiac pacemaker or another implanted electrical device\n* Women who are pregnant or breastfeeding\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant\n* Presence of diagnosed chronic medical condition",true,"ALL","18 Years",{"count":63,"type":64},35,"ESTIMATED","INTERVENTIONAL",[67],"NA","Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.\n\nThe primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.",[70,71,72,73,74,75,76],"Sleep Apnea","Asthma","COPD","Hypertension","Diabetes","Respiratory Disease","Cardiovascular Diseases","2024-08-23",{"date":79,"type":80},"2024-08-26","ACTUAL",{"date":82,"type":80},"2024-07-18",{"date":84,"type":64},"2024-09-30",{"name":5,"class":6},1]