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

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ClinicalTrials.gov Identifier: NCT04249700
Recruitment Status : Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 Curvey 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.

Condition or disease Intervention/treatment Phase
Core Body Temperature 101.3 F Device: Curve Sauna Dome Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Investigating the Effect of Single-session Sauna Use on Body Temperature
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

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.




Primary Outcome Measures :
  1. Sauna Curve Dome successfully induces a core body temperature of 101.3 [ Time Frame: Duration of time in Curve Sauna Dome, up to ~110 minutes ]
    Achieving core body temperature of 101.3 F using a rectal temperature assessment method

  2. Adverse Events Causing Cessation of Curve Sauna Dome Session [ Time Frame: Duration of time in Curve Sauna Dome, up to ~110 minutes ]
    Any adverse event causing stopping of sauna session prior to achieving 101.3 F


Secondary Outcome Measures :
  1. Time to Achieve Core Body Temperature of 101.3 F in Curve Sauna Dome [ Time Frame: Duration of time in Curve Sauna Dome, up to ~110 minutes ]
    Amount of time before participant achieves core body temperature of 101.3 F using a rectal temperature assessment method



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249700


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Mount Zion Health Fund
Investigators
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Principal Investigator: Ashley E Mason, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04249700    
Other Study ID Numbers: HEATBED1
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is currently a feasibility test to ascertain if the procedure can attain the desired outcome. Results will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes