Primary AldosteronismSAUNA-PANCT07796048
Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism
A study testing sauna session in people with Primary Aldosteronism and Hypertension, run by University of Calgary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- sauna session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BP > 160/105 in clinic or > 155/100 on ABPM
- Planning adrenalectomy or other surgery during trial
- Recent hospitalization for any reason, in the past 3 months
- Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months
- CKD, eGFR < 30 ml/min/m2
- Pregnancy, planned pregnancy, or non-use of contraceptive during study
Show all 13Show fewer
- Recent hypotensive event/syncope in the past 3 months
- Any complex medical condition where sauna exposure is not advised
- Planning major dietary change
- History of medication non-adherence
- Night shift worker / at work after 2000h
- Planned vacation/absence during 6-week study
- Inability to read English or consent to participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sauna as an Adjunct to Usual Medical Therapy for Non-reNAl Sodium Elimination in Primary Aldosteronism: Pilot Study (SAUNA-PA)
- 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.
- 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.
- 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.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- sauna session
- Keywords
- sodium, salt, sauna, hypertension, aldosterone
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sauna sessionBehavioural
thrice-weekly, 30-minute sauna session for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sauna intervention | Experimental | Feasibility of thrice-weekly sauna sessions for 2 weeks Receives: Behavioral: sauna session |
What is being measured
The primary outcome is the main question the study is designed to answer.
approach-to-consent ratio
Calculated ratio of subjects approached for recruitment vs number agreed to participate
Measured: from study initiation to end of recruitment window 52 weeks later
Mean monthly enrolment rate
Number of subjects enrolled per month from study opening
Measured: within 6 months of study initiation
Drop out rate
Percentage of subjects who do not complete the 7 week sauna study after enrolment.
Measured: from subject enrolment to intervention completion 7 weeks later.
HILO BP monitor wearability
Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.
Measured: From enrolment to intervention completion, 7 weeks.
Score on the Acceptability of Intervention Measure
Mean score (/20) on the patient-scoring system Acceptability of Intervention Measure
Measured: from enrolment to study intervention completion, 7 weeks.
Sauna Usability
Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions
Measured: 2 weeks of sauna intervention phase
Secondary outcomes (3)
24 hour mean blood pressure
24 hour mean blood pressure from HILO monitoring data
Measured: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Daytime mean blood pressure
Daytime (0700-2300) mean BP from HILO monitor
Measured: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Nighttime mean blood pressure
Mean BP (2300-0700) from HILO BP monitor device
Measured: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Kline, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796048
- Sponsor's protocol ID
- REB26-1232
- Acronym
- SAUNA-PA
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential, identifiable patient information
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sauna as an Adjunct to Usual Medical Therapy for Non-reNAl Sodium Elimination in Primary Aldosteronism: Pilot Study (SAUNA-PA)
- ClinicalTrials.gov ID
- NCT07796048
- Acronym / sponsor ID
- SAUNA-PA / REB26-1232
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- sodium, salt, sauna, hypertension, aldosterone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sauna intervention | Experimental | Behavioral: sauna sessionFeasibility of thrice-weekly sauna sessions for 2 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- BP > 160/105 in clinic or > 155/100 on ABPM
- Planning adrenalectomy or other surgery during trial
- Recent hospitalization for any reason, in the past 3 months
- Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months
- CKD, eGFR < 30 ml/min/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sauna sessionthrice-weekly, 30-minute sauna session for 2 weeks | Behavioural | Sauna intervention |
Primary outcome
approach-to-consent ratio
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
Mean monthly enrolment rate
Time frame: within 6 months of study initiation
Number of subjects enrolled per month from study opening
Drop out rate
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.
HILO BP monitor wearability
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.
Score on the Acceptability of Intervention Measure
Time frame: from enrolment to study intervention completion, 7 weeks.
Mean score (/20) on the patient-scoring system Acceptability of Intervention Measure
Sauna Usability
Time frame: 2 weeks of sauna intervention phase
Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions
3 secondary outcomes
24 hour mean blood pressure
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Daytime mean blood pressure
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Nighttime mean blood pressure
Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. confidential, identifiable patient information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing sauna session in people with Primary Aldosteronism and Hypertension, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Kline, MD (403-955-8327, gakline@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
approach-to-consent ratio (time frame: from study initiation to end of recruitment window 52 weeks later). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.