[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509079":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CO2 Rebreathing","EXPERIMENTAL","Participants will breathe with the rebreather in the supine position until CO2 levels increase between 5-10mmHg. Once CO2 levels are increased, participants will be tilted upright, and will continue to breathe with the rebreather during a 5-min HUT test",[13],"Device: CO2 ReHaler",{"label":15,"type":16,"description":17,"interventionNames":18},"Room Air","NO_INTERVENTION","Participants will breathe room air in the supine position and during a 5-min HUT test",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","CO2 ReHaler","The ReHaler captures expired CO2, which is then re-inhaled. The net effect is a transient increase in CO2.",[9],[26],{"name":27,"affiliation":5,"role":28},"Satish R Raj, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Jacquie Baker, PhD","CONTACT","4032103819","autonomic.research@ucalgary.ca",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":34},"Angela Qi, MD","4032107627",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Calgary","Alberta","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-114.08529,51.05011,{"lat":49,"lon":48},[52,54],{"name":27,"role":32,"phone":53,"phoneExt":18,"email":34},"403-210-6152",{"name":55,"role":32,"phone":56,"phoneExt":18,"email":34},"Robert S Sheldon, MD, PhD","403-220-8191",{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Satish Raj","Professor","100509079","co2-rebreathing-in-noh-a-proof-of-concept-pilot-study-100509079",false,"NCT05908760","CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study","CO2 Rebreathing to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: A Proof-of-Concept Pilot Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Male and Female\n* Physician diagnosis of Neurogenic Orthostatic Hypotension\n* Non-smokers.\n* Able and willing to provide informed consent.\n* Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB.\n\nExclusion Criteria:\n\n* Medical therapies or medications which could interfere with testing of autonomic function\n* Pregnant or breast-feeding females\n* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.\n* Presence of failure of other organ systems or systemic illness that can affect autonomic function or the participant's ability to cooperate. These include dementia, alcohol and\u002For drug abuse, cerebrovascular disease, kidney or liver disease, surgical procedures where the nerves of the sympathetic nervous system have been cut.\n* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.","ALL","18 Years","100 Years",{"count":71,"type":72},28,"ESTIMATED","INTERVENTIONAL",[75],"NA","Neurogenic orthostatic hypotension (nOH) is a chronic condition associated with increased cardiovascular risk and reduced quality of life. On standing, patients with nOH experience a large reduction in blood pressure (BP; at least ≥20\u002F10mmHg, but often much more), which is often accompanied by debilitating symptoms and syncope. A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH. Human bodies naturally produce and exhale CO2. Rebreathe devices offer a simple, cost-effective technology to increase arterial CO2. In brief, rebreathe devices work by capturing expired CO2, which is then re-inhaled. The net effect is a transient increase in CO2. A CO2 rebreathing device may offer a novel hemodynamic therapy for patients with nOH.\n\nThis is a pilot, proof-of-concept study to evaluate a CO2 rebreather to improve blood pressure and orthostatic tolerance in patients with nOH. The hypothesis is that a rebreather will increase CO2 sufficiently enough to improve BP in patients with nOH.\n\nMale and female patients (n=28) will be asked to complete two randomized 70° head-up tilt (HUT) tests breathing either room air or using a CO2 rebreather. Hemodynamics (BP, heart rate, stroke volume, brain blood flow) and orthostatic symptoms will be assessed throughout. Breath-by-breath data will include O2, CO2, respiration rate and tidal volume.\n\nThe primary outcome measure will be the magnitude of the BP response (ΔBP = HUT - Supine) during Room Air vs. Hypercapnia. The primary outcome will be compared between room air and hypercapnia using a paired t-test.",[78,79],"Neurogenic Orthostatic Hypotension","Autonomic Failure","2026-04-29",{"date":82,"type":83},"2026-05-05","ACTUAL",{"date":85,"type":83},"2024-07-30",{"date":87,"type":72},"2030-12-31",{"name":5,"class":6},1]