BridgeMD
New treatment option for Long COVID
Official title Sauna for Long Covid
ClinicalTrials.gov ID: NCT05931497
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 18-65 years of age
- English language proficiency
- Ability to provide informed consent
- Ability to lie supine (on back) for 2 hours (required for sauna sessions)
- Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription...
You likely can't join if
- Fatigue for known reasons other than PASC (e.g. longstanding diagnosis of Chronic Fatigue Syndrome pre-dating Long Covid, low thyroid, multiple...
- Known hypersensitivity to infrared heat exposure, significant history of heat stroke
- Breastfeeding, pregnancy or planned pregnancy during study
- Active suicidal intent
- History of bipolar disorder, psychotic disorders, eating disorders, obsessive compulsive disorder, and/or substance use or dependence (within the...
- Positive urine toxicology screen for illicit drug use
See the full eligibility criteria
- 18-65 years of age
- English language proficiency
- Ability to provide informed consent
- Ability to lie supine (on back) for 2 hours (required for sauna sessions)
- 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...
- 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...
- Individuals of childbearing potential must use an acceptable form of birth control.
- 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...
- Known hypersensitivity to infrared heat exposure, significant history of heat stroke
- Breastfeeding, pregnancy or planned pregnancy during study
- Active suicidal intent
- 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...
- Positive urine toxicology screen for illicit drug use
- Any serious unstable medical condition
- 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).
- Back pain that would interfere with ability to lay on hard surface
- 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
- Breast Implants
- Claustrophobia that would interfere with ability to remain in sauna
- Unsafe cardiac status as defined by abnormal ECG reading at screening visit or as determined by study doctor or subject's physician
- History of or current diagnosis of thrombosis or thrombophilia
- History of hemophilia
- History of febrile seizures or seizure disorders
- Any new treatments/medications for long-COVID that have started in the past 3 months
- A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.