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| Name | Class |
|---|---|
| Mount Zion Health Fund | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The following medications in these timeframes:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley E Mason, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34674592 | Result | 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. |
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This is currently a feasibility test to ascertain if the procedure can attain the desired outcome. Results will be published.
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