Core Body Temperature 101.3 FNCT04249700
Investigating the Effect of Single-session Sauna Use on Body Temperature
A study testing Curve Sauna Dome in people with Core Body Temperature 101.3 F, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Core Body Temperature 101.3 F
- What is being tested?
- Curve Sauna Dome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94115
About this study
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.
Read the 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
- Being tested
- Curve Sauna Dome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curve Sauna DomeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Curve Sauna Dome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Amount of time before participant achieves core body temperature of 101.3 F using a rectal temperature assessment method
Measured: Duration of time in Curve Sauna Dome, up to ~110 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start13 Sep 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Core Body Temperature 101.3 FStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund
- Responsible party
- Sponsor
- Investigators
- Ashley E Mason, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249700
- Sponsor's protocol ID
- HEATBED1
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is currently a feasibility test to ascertain if the procedure can attain the desired outcome. Results will be published.
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.
PubMed 34674592
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Single-session Sauna Use on Body Temperature
- ClinicalTrials.gov ID
- NCT04249700
- Acronym / sponsor ID
- HEATBED1
- Conditions
- Core Body Temperature 101.3 F
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-body Hyperthermia (WBH) | Experimental | Device: Curve Sauna DomeAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curve Sauna DomeAll 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. | Device | Whole-body Hyperthermia (WBH) |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Results publication: PubMed 34674592Mason 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.
- Individual participant dataSharing planned: No. This is currently a feasibility test to ascertain if the procedure can attain the desired outcome. Results will be published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley E Mason, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curve Sauna Dome in people with Core Body Temperature 101.3 F, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.