NCT06125639

Brief Summary

Sauna bathing is a popular, low-cost, and easily accessible type of whole-body thermotherapy that has been used for social, religious, health, and hygienic reasons for thousands of years. There is strong evidence to support the various physiological and psychological benefits of sauna bathing. The positive effects of regular sauna use have been explained by a number of mechanisms of action, including increased cardiac output, reduced peripheral vascular resistance and other physiological changes in cardiovascular parameters such as decreased systolic and/or diastolic blood pressure. Additionally, the psychological impact of sauna bathing may occur due to a combination of factors that include the release of endorphins, relaxation, placebo effects, and psychological and social interactions that likely occur around frequent sauna activity. Taken together, it is possible that acute and regular sauna bathing may impact sleep quality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 20, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 4, 2023

Last Update Submit

November 4, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Objective Sleep - Time in bed

    Total time spent in bed during the night assessed by sleep radar

    5 weeks

  • Objective Sleep - Sleep-onset latency

    The time it takes from when the participant intends to go to sleep and actually starts to sleep assessed by sleep radar

    5 weeks

  • Objective Sleep - Total sleep time

    Total sleep time obtained from sleep onset to time at wake-up assessed by sleep radar

    5 weeks

  • Objective Sleep - Light sleep

    Total amount of time in light sleep assessed by sleep radar

    5 weeks

  • Objective Sleep - Deep sleep

    Total amount of time in deep sleep assessed by sleep radar

    5 weeks

  • Objective Sleep - REM sleep

    Total amount of time in REM sleep assessed by sleep radar

    5 weeks

  • Objective Sleep - Sleep efficiency

    The percentage of total sleep time to lights off and leaving bed assessed by sleep radar

    5 weeks

Secondary Outcomes (4)

  • Subjective Sleep Quality assessed by Karolinska Sleep Diary

    5 weeks

  • Stress level assessed by VAS scale

    5 weeks

  • Positive and Negative Affect Schedule (PANAS)

    baseline, after 1,3,6,9 sauna bathing, after 5 weeks

  • Mood

    baseline, after 1,3,6,9 sauna bathing, after 5 weeks

Study Arms (2)

Sauna Group

EXPERIMENTAL
Behavioral: Sauna Bathing

Control Group

NO INTERVENTION

Interventions

Sauna BathingBEHAVIORAL

Participants will take part in 9 evening sauna bathing session over the course of 3 weeks

Sauna Group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good general health assessed by physician
  • written consent to participate

You may not qualify if:

  • medication or dietary supplements, which could potentially impact the study outcomes
  • history of sleep or neurological disorders
  • regular sauna use
  • professional athlete
  • shift worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 9, 2023

Study Start

October 20, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations