sauna session
Behavioralthrice-weekly, 30-minute sauna session for 2 weeks
NCT Number: NCT07796048
1. Background and Rationale: Primary aldosteronism is a hypertension-related disorder where salt restriction/salt 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. 2. 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. 3. 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/yellow light/green light approach to study feasibility conclusions.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
thrice-weekly, 30-minute sauna session for 2 weeks
Time frame: from study initiation to end of recruitment window 52 weeks later
Calculated ratio of subjects approached for recruitment vs number agreed to participate
Time frame: within 6 months of study initiation
Number of subjects enrolled per month from study opening
Time frame: from subject enrolment to intervention completion 7 weeks later.
Percentage of subjects who do not complete the 7 week sauna study after enrolment.
Time frame: From enrolment to intervention completion, 7 weeks.
Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.
Time frame: from enrolment to study intervention completion, 7 weeks.
Mean score (/20) on the patient-scoring system Acceptability of Intervention Measure
Time frame: 2 weeks of sauna intervention phase
Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
24 hour mean blood pressure from HILO monitoring data
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Daytime (0700-2300) mean BP from HILO monitor
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Mean BP (2300-0700) from HILO BP monitor device
Contact information is provided by the study sponsor or research team.
University of Calgary
Other
Sauna as an Adjunct to Usual Medical Therapy for Non-reNAl Sodium Elimination in Primary Aldosteronism: Pilot Study (SAUNA-PA)
Acronym: SAUNA-PA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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