Investigating the Effect of Single-session Sauna Use on Body Temperature

Whole-body hyperthermia (WBH) to an internal temperature of 38.5 C (101.3 F) using an infrared heating device has been associated with significant reductions in clinical depression. This prior work utilized a WBH medical device that is manufactured in Germany, is not FDA approved, and is not widely available. The goal of this initial pilot project is to ascertain whether an infrared sauna, the Curve Sauna Dome, which is readily accessible (i.e., can be purchased by consumers in the US) can be used to conduct WBH that achieves an internal body temperature of of 101.3 F in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Core Body Temperature 101.3 F
• Intervention / Treatment: Device: Curve Sauna Dome

Detailed Description

Prior work has demonstrated that whole body hyperthermia (WBH) to an internal temperature of 38.5 C (101.3 F) using an infrared heating device is associated with significant reductions in clinical depression. This prior work utilized a Heckel WBH device, a medical device manufactured in Germany that is not FDA-approved and that is not widely available. The goal of this pilot project is to ascertain whether the Curve Sauna Dome, an infrared sauna that is readily accessible (i.e., can be purchased by consumers in the US) can be used to conduct WBH that achieves an internal body temperature of of 38.5 C (101.3 F) in healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or pre-menopausal female volunteers aged 18-45.
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• Able to communicate in English with study personnel.
• Able to lay supine for 2 hours in a sauna.
• BMI <=30
• Waist size of <=40 inches for men or <=35 inches for women
• Have a smartphone
• If female, and sexually active with men, must agree to use non-hormonal birth control (e.g., barrier methods, partner with vasectomy, tubes tied, copper IUD)
• Must have negative pregnancy test day of sauna session

Exclusion Criteria:

• Any history of or current mental health condition
• Any current medical condition requiring medical treatment
• Any history or current substance misuse/abuse
• Regular use of any nicotine products, including cigarettes, e-cigarettes, chewing tobacco, or other forms of nicotine
• Unable to refrain from psychoactive dietary or herbal products, including marijuana, in the 2 weeks prior to study participation
• Breastfeeding or pregnant women, women intending to become pregnant within 6 months of the screening visit
• Sexually active women of child bearing potential who are not using a medically accepted physical means of contraception (defined as non-hormone-based implant, condom, diaphragm, status-post tubal ligation, or partner with vasectomy)
• Current use of hormone-based birth control, such as IUD or oral contraceptive
• Needing to use of any medication that might impact thermoregulatory capacity within 5 days of the sauna session, including: stimulants, diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose aspirin for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, cytokine antagonists
• Current antidepressant medications (all classes) or use within the past 30 days

The following medications in these timeframes:

• Antibiotics (past 60 days)
• Pain medication (opioids) due to procedure, e.g., dental procedure (past 30 days)
• Emergency contraception pill (past 60 days)
• Benzodiazepines, e.g., procedure (past 30 days)
• Use of any other medication that in the judgment of the PI would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to WBH
• Known hypersensitivity to infrared heat exposure
• Unwilling to refrain from sauna use outside of study procedures for one week before and one week after sauna session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Whole-body Hyperthermia (WBH); All participants receive WBH for 80-110 minutes in the Curve Sauna Dome infrared sauna. Participants lay supine in the sauna during this time, and their head is external to the sauna.	Device: Curve Sauna Dome; All participants receive WBH for 80-110 minutes in an infrared sauna. Participants lay supine in the sauna during this time, and their head is external to the sauna.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sauna Curve Dome successfully induces a core body temperature of 101.3	Achieving core body temperature of 101.3 F using a rectal temperature assessment method	Duration of time in Curve Sauna Dome, up to ~110 minutes
Adverse Events Causing Cessation of Curve Sauna Dome Session	Any adverse event causing stopping of sauna session prior to achieving 101.3 F	Duration of time in Curve Sauna Dome, up to ~110 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achieve Core Body Temperature of 101.3 F in Curve Sauna Dome	Amount of time before participant achieves core body temperature of 101.3 F using a rectal temperature assessment method	Duration of time in Curve Sauna Dome, up to ~110 minutes

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Mount Zion Health Fund

Publications and helpful links

General Publications

• Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HEATBED1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is currently a feasibility test to ascertain if the procedure can attain the desired outcome. Results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes