Long COVIDNCT05931497
Sauna for Long Covid
A study testing whole body hyperthermia in people with Long COVID, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- whole body hyperthermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: clinician judgment can override lack of positive COVID test with clear Long Covid onset and presentation)
- 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)
- Individuals of childbearing potential must use an acceptable form of birth control.
Who cannot join
- 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
- 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 (MINI)44
- Positive urine toxicology screen for illicit drug use
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Mischoulon, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Depression Clinical and Research Program
Boston, Massachusetts, 02114
Maren Nyer, PhD, 617-643-4897, mnyer@partners.org
David Mischoulon, MD, PhD, dmischoulon@partners.org
About this study
Official title: A Pilot Study of Whole Body Hyperthermia for Long Covid or Post-Acute Sequelae of COVID-19 (PASC)
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.
Read the detailed description
This proposed trial will examine, for the first-time, study whole-body hyperthermia (WBH) as a treatment for PASC. The investigators will enroll 21 people with PASC who will be randomized into two conditions with different temperature WBH. The primary aims will explore acceptability and feasibility, reduction of fatigue (primary symptom), and potential mechanisms (inflammation and sleep). Inflammation and sleep have both been shown to be dysregulated in PASC and addressed by WBH in other populations. The investigators will use week 2 as the primary endpoint. However, patients will be followed for 4 and 6 weeks to monitor the duration of effect.
- Conditions
- Long COVID
- Being tested
- whole body hyperthermia
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body hyperthermiaDevice
heat will be applied to the participant through a sauna to increase core body temperature
| Study group | Role | What they receive |
|---|---|---|
| verum whole body hyperthermia | Experimental | 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. Receives: Device: whole body hyperthermia |
| sham whole body hyperthermia | Sham comparator | 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. Receives: Device: whole body hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)
provides a more in depth assessment of fatigue as compared to the PROMIS 29 and consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Uses a range of 7-35, higher scores indicate higher fatigue.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Secondary outcomes (10)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
assesses seven health domains (i.e., physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. There is no total score, and scores range from 4-10 for each health domain (with 4 items for each of the 7 health domains). Scores are transformed into t scores with higher scores indicating better health.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Patient Health Questionnaire-9 (PHQ)
a well-established, brief self-administered 9-item depression screening and monitoring tool. Uses a range of 0-27 with higher scores indicating greater depressive symptoms.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
The Perceived Stress Scale (PSS)
consists of 10 items and measures the frequency with which perceived stressful life situations are experienced. Scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Patient-Reported Outcomes Measurement Information System Cognitive Abilities
items target positive self-assessments of cognitive functioning with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate better perceived cognitive functioning.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Patient-Reported Outcomes Measurement Information System Cognitive Concerns
items are worded negatively and express concerns in the same areas as in the Patient-Reported Outcomes Measurement Information System Cognitive Abilities with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate greater cognitive concerns.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Positive and Negative Affective Schedule (PANAS)
consists of two 10-item mood scales to measure positive and negative affect. Raw scores range from 10 to 50. Higher scores indicate more of a positive affect.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
The Composite Autonomic Symptom Score (COMPASS-31)
consists of 31 items and measures autonomic and neurodegenerative system symptoms. Total scores range from 0 to 100 with greater scores indicating greater autonomic dysfunction.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
13-item questionnaire designed to assess the severity of fatigue and its impact on daily functioning and quality of life. Respondents rate items on a 5-point scale, with higher scores indicating less fatigue. Total scores can range between 0 and 52.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Long-COVID Symptom Tool (Long-COVID ST)
assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. Scores can range from 0 to 53 with higher scores indicating greater severity of symptoms.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Long-COVID Impact Tool (Long-COVID IT)
assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. The scale also measures the impact from these symptoms. Scores can range from 0 to 60 with higher scores indicating greater life impact.
Measured: 2-weeks (primary endpoint) follow up at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Aug 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of two WBH groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Maren Nyer, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931497
- Sponsor's protocol ID
- 2023p000852
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Whole Body Hyperthermia for Long Covid or Post-Acute Sequelae of COVID-19 (PASC)
- ClinicalTrials.gov ID
- NCT05931497
- Acronym / sponsor ID
- 2023p000852
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposed trial will examine, for the first-time, study whole-body hyperthermia (WBH) as a treatment for PASC. The investigators will enroll 21 people with PASC who will be randomized into two conditions with different temperature WBH. The primary aims will explore acceptability and feasibility, reduction of fatigue (primary symptom), and potential mechanisms (inflammation and sleep). Inflammation and sleep have both been shown to be dysregulated in PASC and addressed by WBH in other populations. The investigators will use week 2 as the primary endpoint. However, patients will be followed for 4 and 6 weeks to monitor the duration of effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two WBH groups.
| Arm | Type | Receives |
|---|---|---|
| verum whole body hyperthermia | Experimental | Device: whole body hyperthermiaWBH 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 whole body hyperthermia | Sham comparator | Device: whole body hyperthermiaThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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: clinician judgment can override lack of positive COVID test with clear Long Covid onset and presentation)
Key exclusion criteria (18 listed)
- 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
- 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 (MINI)44
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body hyperthermiaheat will be applied to the participant through a sauna to increase core body temperature | Device | sham whole body hyperthermia, verum whole body hyperthermia |
Primary outcome
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
provides a more in depth assessment of fatigue as compared to the PROMIS 29 and consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Uses a range of 7-35, higher scores indicate higher fatigue.
10 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Patient Health Questionnaire-9 (PHQ)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
The Perceived Stress Scale (PSS)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Patient-Reported Outcomes Measurement Information System Cognitive Abilities
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Patient-Reported Outcomes Measurement Information System Cognitive Concerns
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Positive and Negative Affective Schedule (PANAS)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
The Composite Autonomic Symptom Score (COMPASS-31)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Long-COVID Symptom Tool (Long-COVID ST)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Long-COVID Impact Tool (Long-COVID IT)
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Mischoulon, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body hyperthermia in people with Long COVID, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maren Nyer, PhD (6072796290, mnyer@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.