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

NCT04249700 | Completed FDA Device

• 1 other identifier: HEATBED1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Core Body Temperature 101.3 F

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time to Achieve Core Body Temperature of 101.3 F in Curve Sauna Dome

  Duration of time in Curve Sauna Dome, up to ~110 minutes

Study Arms (1)

Whole-body Hyperthermia (WBH)

EXPERIMENTAL

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

Interventions

Curve Sauna Dome DEVICE

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.

Whole-body Hyperthermia (WBH)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 34674592 RESULT

Study Officials

• Ashley E Mason, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 31, 2020
• Study Start: September 13, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)