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Procedure
Sauna Therapy for Long Covid
N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to lie supine (on back) for 2 hours (required for sauna sessions)
18-65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks
Awards & highlights
Study Summary
This trial looks into whether using a sauna-like environment can help reduce symptoms of Long Covid.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort due to heat, dehydration, low blood pressure upon standing, lightheadedness or fainting. People with heart issues or sensitivity to heat should avoid this treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can lie on my back for 2 hours.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)
Secondary outcome measures
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Trial Design
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 101.3°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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,334 Total Patients Enrolled
30 Trials studying COVID-19
10,060,649 Patients Enrolled for COVID-19
University of California, San FranciscoOTHER
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15,236,450 Total Patients Enrolled
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569,460 Patients Enrolled for COVID-19
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can lie on my back for 2 hours.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 had COVID-19 symptoms and tested positive for it over 12 weeks ago.I have a history or current diagnosis of blood clots.You have tested positive for using illegal drugs in a urine test.You have a heart condition that is not safe for the study, as determined by an abnormal ECG reading or your doctor.The study leader believes I can safely complete the study without risking its integrity.You have a known allergy to exposure to infrared heat.I experience fatigue not related to post-acute sequelae of COVID-19.I have a fever over 99°F with no known cause.I cannot fit into a sauna device due to my body size or shape.You are afraid of small, enclosed spaces and it would make it hard for you to stay in a sauna.You have breast implants.You have recently expressed serious thoughts about hurting yourself.I do not have any serious unstable medical conditions.I am between 18 and 65 years old.You have a score of 21 or more on the fatigue test at the initial screening.
Research Study Groups:
This trial has the following groups:- Group 1: verum whole body hyperthermia
- Group 2: sham whole body hyperthermia
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatrics being considered for enlistment into this trial?
"This clinical trial is targeting individuals aged between 18 and 65 years old."
Answered by AI
Is there any way I can participate in this research?
"For admittance to this research, applicants must be 18-65 years old and have a confirmed coronavirus infection. Currently the trial is accepting 21 participants in total."
Answered by AI
Are there still opportunities for participants in this experiment?
"Per data available on clinicaltrials.gov, this clinical trial is not currently recruiting patients as it was last updated at the end of June 2023. Nevertheless, there are 117 other trials in progress that applicants can apply to join."
Answered by AI
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