[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609649":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":11,"studyPopulation":21,"armGroups":11,"interventions":22,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":63,"collaborators":65,"id":69,"slug":11,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":11,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Life Detection Technologies","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements",null,"Day 1",[14,16],{"measure":15,"description":11,"timeFrame":12},"Mean absolute relative difference for each of HR and RR between the DistaSense and the reference",{"measure":17,"description":11,"timeFrame":12},"Deming regression for each of the HR and RR data",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":19,"timePerspective":20,"maskingInfo":11},"COHORT","PROSPECTIVE","Volunteers will be recruited via research subject databases from each site.",[23],{"type":24,"name":25,"description":26,"armGroupLabels":11,"otherNames":11},"DIAGNOSTIC_TEST","DistaSense and Polysomnography","All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.",[28,48],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Clayton Sleep Institute","RECRUITING","St Louis","Missouri","63123","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-90.19789,38.62727,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Chief Operating Officer; Co-Director CSI Research Center","CONTACT","314-645-5855","UhlesM@claytonsleep.com",{"facility":49,"status":30,"city":50,"state":51,"zip":52,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"CTI Clinical Research Center","Cincinnati","Ohio","45212",{"type":37,"coordinates":54},[55,56],-84.51439,39.12711,{"lat":56,"lon":55},[59],{"name":60,"role":45,"phone":61,"phoneExt":11,"email":62},"Senior Director of Research Site Operations","513-721-3868","aroth@ctifacts.com",{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[66],{"name":67,"class":68},"Nilo Medical Consulting Group","UNKNOWN","100609649",false,"NCT07217327","The DistaSense VITALS Study","DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies","VITALS","Inclusion Criteria:\n\n1. Age ≥ 22 years\n2. Fluent in English\n3. Willing and cognitively able to provide informed consent\n4. BMI \\\u003C 36\n5. Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)\n6. Able to complete the scripted portion of the evaluation\n\nExclusion Criteria:\n\n1. Pregnant\n2. Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment\n3. Subjects with electronic implants of any kind (e.g. pacemaker)\n4. Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder",true,"ALL","22 Years",{"count":80,"type":81},20,"ESTIMATED","OBSERVATIONAL","A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology.",[85],"Detection of Heart Rate and Respiratory Rate","2025-10-31",{"date":88,"type":89},"2025-11-03","ACTUAL",{"date":91,"type":89},"2025-08-13",{"date":93,"type":81},"2025-11",{"name":5,"class":6},2]