Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
21 participants
INTERVENTIONAL
2026-08-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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verum whole body hyperthermia
WBH will be completed with a Clearlight Sauna Dome and ancillary equipment to monitor core body temperature. For the verum WBH, participants will be brought to a core body temperature of 101.3°F.
whole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature
sham whole body hyperthermia
The sham condition will be identical to the active WBH condition. Time and other procedures will be consistent. Mild heat will be used to mimic an active WBH session.
whole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature
Interventions
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whole body hyperthermia
heat will be applied to the participant through a sauna to increase core body temperature
Eligibility Criteria
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Inclusion Criteria
2. English language proficiency
3. Ability to provide informed consent
4. Ability to lie supine (on back) for 2 hours (required for sauna sessions)
5. Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening (Note: clinician judgment can override lack of positive COVID test with clear Long Covid onset and presentation)
6. The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF43) raw score of 21 or greater at Screening (onset of fatigue confirmed post-infection as in other studies of PASC)
7. Individuals of childbearing potential must use an acceptable form of birth control.
Exclusion Criteria
2. Known hypersensitivity to infrared heat exposure, significant history of heat stroke
3. Breastfeeding, pregnancy or planned pregnancy during study
4. Active suicidal intent
5. History of bipolar disorder, psychotic disorders, eating disorders, obsessive compulsive disorder, and/or substance use or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)44
6. Positive urine toxicology screen for illicit drug use
7. Any serious unstable medical condition
8. Inability to fit into the sauna device. Morbid obesity (BMI \> 40) and/or body shape that might increase the risk of cutaneous burning from the device (because of skin being too close to the heat).
9. Back pain that would interfere with ability to lay on hard surface
10. Using medication that might impact thermoregulatory capacity and cannot be held for an appropriate length (at least one half-life) as determined by clinician judgment prior to receiving WBH treatment
11. Breast Implants
12. Claustrophobia that would interfere with ability to remain in sauna
13. Unsafe cardiac status as defined by abnormal ECG reading at screening visit or as determined by study doctor or subject's physician
14. History of or current diagnosis of thrombosis or thrombophilia
15. History of hemophilia
16. History of febrile seizures or seizure disorders
17. Any new treatments/medications for long-COVID that have started in the past 3 months
18. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity.
18 Years
65 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Maren Nyer
Clinical Psychologist
Locations
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Depression Clinical and Research Program
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Maren Nyer, PhD
Role: primary
David Mischoulon, MD, PhD
Role: backup
Other Identifiers
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2023p000852
Identifier Type: -
Identifier Source: org_study_id