21 Participants Needed

Sauna Therapy for Long Covid

MN
DM
Overseen ByDavid Mischoulon, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Whole Body Hyperthermia for Long Covid?

Whole Body Hyperthermia (WBH) has shown positive effects in other conditions, such as improving quality of life and cardiac function in chronic heart failure patients, and reducing AIDS-related events in HIV patients. These findings suggest that WBH might help improve symptoms in Long Covid patients by enhancing overall health and function.12345

How does sauna therapy differ from other treatments for Long Covid?

Sauna therapy, specifically whole body hyperthermia, is unique because it involves raising the body's core temperature to improve health, which is different from typical drug-based treatments. This method has been used for other conditions like heart failure and chronic fatigue, suggesting it may help improve symptoms by enhancing circulation and reducing inflammation.13467

What is the purpose of this trial?

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.

Eligibility Criteria

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.
See 3 more

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.
See 12 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: verum whole body hyperthermiaExperimental Treatment1 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 101.3Β°F.
Group II: sham whole body hyperthermiaPlacebo Group1 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:

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Approved in European Union as Whole Body Hyperthermia for:
  • Depression
  • Other conditions
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Approved in United States as Whole Body Hyperthermia for:
  • Major Depressive Disorder
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Approved in Switzerland as Whole Body Hyperthermia for:
  • Depression

Find a Clinic Near You

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+

Findings from Research

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

References

Extracorporeal whole body hyperthermia treatments for HIV infection and AIDS. [2014]
Health management of patients with COVID-19: is there a room for hydrotherapeutic approaches? [2022]
Anaesthesiological experiences with whole body hyperthermia. [2019]
Waon therapy improves quality of life as well as cardiac function and exercise capacity in patients with chronic heart failure. [2015]
[Experiences with therapeutic whole-body hyperthermia]. [2007]
Sauna as a valuable clinical tool for cardiovascular, autoimmune, toxicant- induced and other chronic health problems. [2022]
Repeated sauna therapy improves myocardial perfusion in patients with chronically occluded coronary artery-related ischemia. [2022]
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