Sauna Therapy for Long Covid

Overseen By David Mischoulon, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Illicit drugs, Thermoregulatory meds

Disqualifiers: Pregnancy, Bipolar, Obesity, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether using a sauna-like environment for Whole Body Hyperthermia (also known as Heat Therapy) can reduce symptoms of Long Covid. Participants will undergo either real or mild "sham" heat sessions to evaluate the treatment's effectiveness. Suitable candidates have had a confirmed COVID-19 infection by a positive test at least 12 weeks ago and continue to experience fatigue.

As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research on innovative therapies for Long Covid.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications if they affect your body's ability to regulate heat and cannot be paused safely. This will be determined by a clinician before you start the sauna therapy.

What prior data suggests that this procedure is safe for Long Covid patients?

Research shows that Whole Body Hyperthermia, a treatment similar to using a sauna, may help reduce symptoms of Long Covid. Although specific safety data from these studies is not yet available, similar treatments offer insights. Studies on heat therapy for COVID-19 recovery suggest it is generally safe, with most participants not experiencing serious side effects.

This trial is in the early stages, focusing on the practicality and effectiveness of the treatment rather than proving complete safety. As a result, safety information is still being gathered. However, saunas and similar treatments have been used safely for other health issues, providing some indirect evidence that Whole Body Hyperthermia might be safe for many people. Consulting a healthcare provider before joining a trial is always advisable to understand any personal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whole body hyperthermia (WBH) for Long Covid because it offers a unique, non-pharmacological approach to managing symptoms. Unlike traditional treatments that often focus on medications to reduce inflammation or manage specific symptoms, WBH involves raising the body's core temperature using a sauna-like environment. This method may help improve circulation, boost immune response, and alleviate fatigue and pain associated with Long Covid. The therapy's potential to provide relief without the side effects commonly associated with medication makes it a promising option for those seeking alternative treatment methods.

What evidence suggests that Whole Body Hyperthermia might be an effective treatment for Long Covid?

Research has shown that whole body hyperthermia (WBH) might help ease symptoms of Long Covid. In this trial, participants will join either a verum WBH group, where their core body temperature will reach 101.3°F, or a sham WBH group, which will simulate an active WBH session with mild heat. Some studies suggest that WBH could have positive effects when combined with other treatments. In one study, patients experienced some symptom relief when WBH was part of their care. WBH raises the body's core temperature, similar to a sauna session, which might help patients feel better. However, more research is needed to fully understand its effectiveness in treating Long Covid. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who've had COVID-19 and suffer from Long Covid fatigue. They must be able to lie on their back for sauna sessions, use birth control if applicable, and not have any serious unstable medical conditions or certain mental health disorders.

Inclusion Criteria

I can lie on my back for 2 hours.

I had COVID-19 symptoms and tested positive for it over 12 weeks ago.

Individuals of childbearing potential must use an acceptable form of birth control.

Exclusion Criteria

I am not on medications that affect body temperature regulation.

You have a history of certain mental health conditions or substance abuse within the last year.

I have a history or current diagnosis of blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo whole body hyperthermia (WBH) treatment in a sauna-like environment to study its effects on Long Covid symptoms

2 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 4 and 6 weeks

4 weeks

Follow-up assessments at 4 and 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole Body Hyperthermia

Trial Overview The study tests the effects of Whole Body Hyperthermia in a sauna-like setting on Long Covid symptoms. Participants will undergo this treatment to see if it can reduce fatigue associated with Post-COVID Syndrome.

How Is the Trial Designed?

Group I: verum whole body hyperthermia Experimental Treatment 1 Intervention

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.

Group II: sham whole body hyperthermia Placebo Group 1 Intervention

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 is already approved in European Union, United States, Switzerland for the following indications:

Approved in European Union as Whole Body Hyperthermia for:

• Depression
• Other conditions

Approved in United States as Whole Body Hyperthermia for:

• Major Depressive Disorder

Approved in Switzerland as Whole Body Hyperthermia for:

• Depression

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Regular sauna therapy is generally safe and provides various health benefits, particularly for individuals with conditions like hypertension, heart failure, and chronic pain, based on historical and contemporary studies.

However, caution is advised for pregnant individuals, as high temperatures from sauna use may pose risks to fetal development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sauna as a valuable clinical tool for cardiovascular, autoimmune, toxicant- induced and other chronic health problems. Crinnion, WJ.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06928116

Heat thErapy And mobiLity in COVID-19 Survivors This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40336247/

Whole-body hyperthermia as part of a multimodal treatment ... Conclusions: Study results provide preliminary evidence for potentially positive effects of WBH in the setting of this study, in which it is ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2025.2488792

Whole-body hyperthermia as part of a multimodal treatment ... Study results provide preliminary evidence for potentially positive effects of WBH in the setting of this study, in which it is embedded in a multimodal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05931497

Study Details | NCT05931497 | Sauna for Long Covid 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 ...

5. researchgate.net researchgate.net/publication/391566899_Whole-body_hyperthermia_as_part_of_a_multimodal_treatment_for_patients_with_post-covid_syndrome_-_a_case_series

Whole-body hyperthermia as part of a multimodal treatment ... Relatively little is known about the effect of whole-body hyperthermia (WBH) in the treatment of PCS. Methods We retrospectively analyzed the ...

6. reaganudall.org reaganudall.org/clinical-trial/sauna-long-covid

Sauna for Long Covid Research suggests that Whole Body Hyperthermia in a sauna-like environment can reducesymptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid ...