[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654100":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":50,"interventions":57,"overallOfficials":44,"centralContacts":63,"locations":44,"responsibleParty":69,"collaborators":44,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":44,"studyType":87,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":99,"whyStopped":44,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},{"fullName":5,"class":6},"University of Calgary","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":44},[9,13,17,21,25,29],{"measure":10,"description":11,"timeFrame":12},"approach-to-consent ratio","Calculated ratio of subjects approached for recruitment vs number agreed to participate","from study initiation to end of recruitment window 52 weeks later",{"measure":14,"description":15,"timeFrame":16},"Mean monthly enrolment rate","Number of subjects enrolled per month from study opening","within 6 months of study initiation",{"measure":18,"description":19,"timeFrame":20},"Drop out rate","Percentage of subjects who do not complete the 7 week sauna study after enrolment.","from subject enrolment to intervention completion 7 weeks later.",{"measure":22,"description":23,"timeFrame":24},"HILO BP monitor wearability","Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.","From enrolment to intervention completion, 7 weeks.",{"measure":26,"description":27,"timeFrame":28},"Score on the Acceptability of Intervention Measure","Mean score (\u002F20) on the patient-scoring system Acceptability of Intervention Measure","from enrolment to study intervention completion, 7 weeks.",{"measure":30,"description":31,"timeFrame":32},"Sauna Usability","Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions","2 weeks of sauna intervention phase",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"24 hour mean blood pressure","24 hour mean blood pressure from HILO monitoring data","3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.",{"measure":39,"description":40,"timeFrame":37},"Daytime mean blood pressure","Daytime (0700-2300) mean BP from HILO monitor",{"measure":42,"description":43,"timeFrame":37},"Nighttime mean blood pressure","Mean BP (2300-0700) from HILO BP monitor device",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":6,"observationalModel":44,"timePerspective":44,"maskingInfo":48},"NA","SINGLE_GROUP",{"masking":49,"maskingDescription":44,"whoMasked":44},"NONE",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"Sauna intervention","EXPERIMENTAL","Feasibility of thrice-weekly sauna sessions for 2 weeks",[56],"Behavioral: sauna session",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":44},"BEHAVIORAL","sauna session","thrice-weekly, 30-minute sauna session for 2 weeks",[52],[64],{"name":65,"role":66,"phone":67,"phoneExt":44,"email":68},"Gregory Kline, MD","CONTACT","403-955-8327","gakline@ucalgary.ca",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Gregory Kline","Clinical Professor of Medicine","100654100","regular-sauna-use-to-lower-blood-pressure-in-primary-aldosteronism-100654100",false,"NCT07796048","Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism","Sauna as an Adjunct to Usual Medical Therapy for Non-reNAl Sodium Elimination in Primary Aldosteronism: Pilot Study (SAUNA-PA)","SAUNA-PA","Inclusion Criteria:\n\n* a) Age 18-65 b) Hypertension with PA diagnosed using Endocrine Society's 2025 criteria c) Stable medical therapy with no change in dose\u002Fagent in prior 6 weeks d) BP uncontrolled, clinic \\> 140\u002F90 or ABPM mean \\> 135\u002F85 e) Dietary sodium moderate or higher (\\> 128 mmol\u002Fd) f) Subject owns iPhone (12-16) or Android and willing to install HiLo app\n\nExclusion Criteria:\n\n1. BP \\> 160\u002F105 in clinic or \\> 155\u002F100 on ABPM\n2. Planning adrenalectomy or other surgery during trial\n3. Recent hospitalization for any reason, in the past 3 months\n4. Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months\n5. CKD, eGFR \\\u003C 30 ml\u002Fmin\u002Fm2\n6. Pregnancy, planned pregnancy, or non-use of contraceptive during study\n7. Recent hypotensive event\u002Fsyncope in the past 3 months\n8. Any complex medical condition where sauna exposure is not advised\n9. Planning major dietary change\n10. History of medication non-adherence\n11. Night shift worker \u002F at work after 2000h\n12. Planned vacation\u002Fabsence during 6-week study\n13. Inability to read English or consent to participation","ALL","18 Years","65 Years",{"count":85,"type":86},10,"ESTIMATED","INTERVENTIONAL",[46],"1. Background and Rationale: Primary aldosteronism is a hypertension-related disorder where salt restriction\u002Fsalt loss is a central part of therapy. Dietary salt restriction to sufficient degree is very difficult for most patients and thus medications are frequently required to control blood pressure. Non-pharmacologic means of reducing total body sodium and blood pressure are required and desired by patients. Sauna bathing is a traditional wellness practice associated with extensive sweating and therefore salt loss. We wish to study whether incorporation of sauna bathing into a treatment plan for primary aldosteronism might lower blood pressure without increased medications. A pilot feasibility study is required prior to design of a larger controlled clinical trial. We are looking to conduct a short term simulated sauna study to assess patient acceptability and study feasibility as the primary outcomes.\n2. Research Questions and Objectives: This study will test the feasibility of having patients add regular sauna usage to their weekly lifestyle, while being treated for hypertension due to primary aldosteronism. The primary objective will be to assess patient recruitment rates, subject retention, patient acceptability, and patient adherence to regular sauna intervention during a 2-week period, using an a priori \"traffic light\" decision matrix. The secondary objectives will be to explore change in blood pressure, as measured by a wearable, continuous BP wrist monitor, before and after a 2 week sauna intervention.\n3. Methods: The study will occur in the context of routine ongoing care in the Endocrine Hypertension Clinic. Ten patients with primary aldosteronism will be recruited to a 7 week study where we will observe the feasibility and acceptability of wearing a continuous, cuffless, wrist BP monitoring device for 2-week periods prior to, during, and after a 2 week \"sauna\" therapy program. The sauna therapy will consist of three 30 minute visits to a commercially licensed and insured local sauna club each week for 2 weeks. Standardized subject experience questionnaires will collect feasibility and acceptability data which will be analyzed with a standard red light\u002Fyellow light\u002Fgreen light approach to study feasibility conclusions.",[91,92],"Primary Aldosteronism","Hypertension",[94,95,96,97,98],"sodium","salt","sauna","hypertension","aldosterone","NOT_YET_RECRUITING","2026-08-27",{"date":102,"type":103},"2026-08-31","ACTUAL",{"date":105,"type":86},"2026-09-30",{"date":107,"type":86},"2028-09-30",{"name":5,"class":6}]