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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06125639
Other study ID # AWF_SKN_1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date May 2024

Study information

Verified date November 2023
Source University School of Physical Education, Krakow, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - good general health assessed by physician - written consent to participate Exclusion Criteria: - medication or dietary supplements, which could potentially impact the study outcomes - history of sleep or neurological disorders - regular sauna use - professional athlete - shift worker

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland University School of Physical Education in Cracow Kraków
Poland University School of Physical Education in Cracow Kraków

Sponsors (2)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland University of Bergen

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Sleep - Time in bed Total time spent in bed during the night assessed by sleep radar 5 weeks
Primary 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
Primary Objective Sleep - Total sleep time Total sleep time obtained from sleep onset to time at wake-up assessed by sleep radar 5 weeks
Primary Objective Sleep - Light sleep Total amount of time in light sleep assessed by sleep radar 5 weeks
Primary Objective Sleep - Deep sleep Total amount of time in deep sleep assessed by sleep radar 5 weeks
Primary Objective Sleep - REM sleep Total amount of time in REM sleep assessed by sleep radar 5 weeks
Primary Objective Sleep - Sleep efficiency The percentage of total sleep time to lights off and leaving bed assessed by sleep radar 5 weeks
Secondary Subjective Sleep Quality assessed by Karolinska Sleep Diary 5 weeks
Secondary Stress level assessed by VAS scale VAS scale is a 11-item self-report measure for stress. Answers range from 0 (no stress) to 10 (worst stress). 5 weeks
Secondary Positive and Negative Affect Schedule (PANAS) The PANAS is a 20-item self-report measure for positive and negative affect. baseline, after 1,3,6,9 sauna bathing, after 5 weeks
Secondary Mood Mood Adjective Check List (UMACL) will be used to assess mood (Mathews, Chamberlain & Jones, 1990, adapted to Polish by Ewa Gorynska, 2005). UMACL measures mood in three dimensions of the core affect: Tense Arousal (minimum value: 9, maximum value: 36), Energetic Arousal (minimum value: 10, maximum value: 40), and Hedonic Tone (minimum value: 10, maximum value: 40), with higher scores representing higher levels of the mood dimensions. baseline, after 1,3,6,9 sauna bathing, after 5 weeks
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