ClinicalTrials.gg
Not yet recruitingNCT07796048SAUNA-PAUpdated Aug 31, 2026

Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism

An interventional study of sauna session in Primary Aldosteronism and Hypertension, sponsored by University of Calgary. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of Calgary · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Primary Aldosteronism
  • Hypertension

Keywords

  • sodium
  • salt
  • sauna
  • hypertension
  • aldosterone
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 10 is below the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  1. BP > 160/105 in clinic or > 155/100 on ABPM
  2. Planning adrenalectomy or other surgery during trial
  3. Recent hospitalization for any reason, in the past 3 months
  4. Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months
  5. CKD, \< 30 ml/min/m2
  6. Pregnancy, planned pregnancy, or non-use of during study
  7. Recent hypotensive event/syncope in the past 3 months
  8. Any complex medical condition where sauna exposure is not advised
  9. Planning major dietary change
  10. History of medication non-adherence
  11. Night shift worker / at work after 2000h
  12. Planned vacation/absence during 6-week study
  13. Inability to read English or consent to participation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Sauna intervention

    Feasibility of thrice-weekly sauna sessions for 2 weeks

    Behavioral: sauna session

Interventions

  • Behavioralsauna session

    thrice-weekly, 30-minute sauna session for 2 weeks

06

What researchers measure

Primary outcomes

  1. approach-to-consent ratio

    Calculated ratio of subjects approached for recruitment vs number agreed to participate

    Time frame: from study initiation to end of recruitment window 52 weeks later

  2. Mean monthly enrolment rate

    Number of subjects enrolled per month from study opening

    Time frame: within 6 months of study initiation

  3. Drop out rate

    Percentage of subjects who do not complete the 7 week sauna study after enrolment.

    Time frame: from subject enrolment to intervention completion 7 weeks later.

  4. HILO BP monitor wearability

    Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.

    Time frame: From enrolment to intervention completion, 7 weeks.

  5. Score on the Acceptability of Intervention Measure

    Mean score (/20) on the patient-scoring system Acceptability of Intervention Measure

    Time frame: from enrolment to study intervention completion, 7 weeks.

  6. Sauna Usability

    Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions

    Time frame: 2 weeks of sauna intervention phase

Secondary outcomes

  1. 24 hour mean blood pressure

    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.

  2. Daytime mean blood pressure

    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.

  3. Nighttime mean blood pressure

    Mean BP (2300-0700) from HILO BP monitor device

    Time frame: 3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — confidential, identifiable patient information

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796048
Responsible party
Gregory Kline (Clinical Professor of Medicine, University of Calgary) — Principal investigator
First posted
Aug 31, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Aug 31, 2026

Study contacts

Gregory Kline, MD
Contact
gakline@ucalgary.ca
403-955-8327

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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