NCT06875466

Brief Summary

Cardiovascular disease (CVD) is the leading cause of mortality in Aotearoa New Zealand, with hypertension being a major risk factor that remains difficult to manage with medication. Finnish sauna bathing (FSB), a widely practiced form of heat therapy, has been linked to lower risks of CVD, stroke, and overall mortality. Traditionally, FSB is combined with cold water immersion (CWI), but the combined effects of these therapies remain under explored. While sauna research often focuses on physiological aspects, this study aims to take a holistic approach to understanding its impact on cardiovascular health.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 9, 2025

Last Update Submit

March 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 24 hour ambulatory blood pressure

    This measure will be taken before and after the intervention. There are four sections of the questionnaire. The first two sections use the scale 1 - 5 where 1 = never, 2 = rarely, 3 = occasionally, 4 = regularly, 5 = constantly. A higher score means a worse outcome. Section three uses the scale 1 - 5 where 1 = not at all, 2 = not really, 3 = sometimes, 4 = yes, 5 = yes, absolutely; in this section a higher score means a better outcome. Section four uses a scale 1 - 5 where 1 = strongly disagree, 2 = disagree, 3 = not sure, 4 = agree, 5 = strongly agree; a higher score means a better outcome.

    8 weeks

Secondary Outcomes (2)

  • Quality of life questionnaire

    8 weeks

  • PROMIS Sleep Questionnaire

    8 weeks

Study Arms (1)

Sauna Bathing

EXPERIMENTAL

Participants receive the sauna bathing treatment (1 session per week for 8 weeks)

Device: Sauna bathing

Interventions

Finnish sauna bathing, participants will sauna once per week for 8 weeks

Sauna Bathing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SBP: 110-179 mmHg; DBP 60-99 mmHg)
  • y old.
  • Participants who are prescribed anti-hypertensive or dyslipidaemia medications will be included but must be on a stable dose for at least 30 days.

You may not qualify if:

  • stable or unstable angina
  • recent myocardial infarction (\<3 months)
  • orthostatic hypotension
  • severe aortic stenosis
  • pregnancy
  • acute infectious diseases
  • rheumatoid arthritis in the acute inflammatory phase
  • fever for any reason
  • any other medical condition deemed a risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Health

Tauranga, 3110, New Zealand

RECRUITING

Study Officials

  • Anna Rolleston, PhD

    The Centre for Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rolleston, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 13, 2025

Study Start

March 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations