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

NCT ID: NCT04249700

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2020-04-01

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.

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.

Conditions

Core Body Temperature 101.3 F

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Curve Sauna Dome

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Zion Health Fund

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley E Mason, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34674592 (View on PubMed)

Other Identifiers

HEATBED1

Identifier Type: -

Identifier Source: org_study_id