Recruiting

Sauna

Sponsor:

Massachusetts General Hospital

Code:

NCT05931497

Conditions

Long COVID

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

whole body hyperthermia

Study Details

Brief summary:

Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The investigators aim to study the feasibility and treatment effect of this procedure for patients experiencing Long Covid symptoms.

Conditions

Long COVID

Study ID

NCT05931497

Start date

Aug 1, 2026

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18-65 years of age
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:

1. Fatigue for known reasons other than PASC (e.g. longstanding diagnosis of Chronic Fatigue Syndrome pre-dating Long Covid, low thyroid, multiple sclerosis, AIDS related fatigue, mononucleosis), as determined by clinical discretion of study investigators
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.

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

whole body hyperthermia

heat will be applied to the participant through a sauna to increase core body temperature

Primary outcome measure

  • The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF) [ Time Frame: 2-weeks (primary endpoint) follow up at 6 weeks ]

Central Contacts and Locations

Central contacts

David Mischoulon, MD, PhD

dmischoulon@mgh.harvard.edu

Locations

Depression Clinical and Research Program

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

David Mischoulon, MD, PhD

dmischoulon@partners.org

Principal Investigator:

Maren Nyer, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-13.