NCT07796048Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Calgary
- Diseases
- High blood pressure
- NCT number
- NCT07796048
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 30 Sept 2026 to the primary completion date, 30 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planning adrenalectomy or other surgery during trial
Other illness
- Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months
- Any complex medical condition where sauna exposure is not advised
- History of medication non-adherence
Lab values
- CKD, eGFR \< 30 ml/min/m2
Other
- BP \> 160/105 in clinic or \> 155/100 on ABPM
- Recent hospitalization for any reason, in the past 3 months
- Pregnancy, planned pregnancy, or non-use of contraceptive during study
- Recent hypotensive event/syncope in the past 3 months
- Planning major dietary change
- Night shift worker / at work after 2000h
- Planned vacation/absence during 6-week study
- Inability to read English or consent to participation
Who the study is looking for
- a) Age 18-65 b) Hypertension with PA diagnosed using Endocrine Society's 2025 criteria c) Stable medical therapy with no change in dose/agent in prior 6 weeks d) BP uncontrolled, clinic \> 140/90 or ABPM mean \> 135/85 e) Dietary sodium moderate or higher (\> 128 mmol/d) f) Subject owns iPhone (12-16) or Android and willing to install HiLo app
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.