Sauna for Long Covid

NCT05931497 | Recruiting DMC

• 1 other identifier: 2023p000852
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• 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.

  2-weeks (primary endpoint) follow up at 6 weeks

Secondary Outcomes (10)

• Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  2-weeks (primary endpoint) follow up at 6 weeks

• Patient Health Questionnaire-9 (PHQ)

  2-weeks (primary endpoint) follow up at 6 weeks

• The Perceived Stress Scale (PSS)

  2-weeks (primary endpoint) follow up at 6 weeks

• Patient-Reported Outcomes Measurement Information System Cognitive Abilities

  2-weeks (primary endpoint) follow up at 6 weeks

• Patient-Reported Outcomes Measurement Information System Cognitive Concerns

  2-weeks (primary endpoint) follow up at 6 weeks

Study Arms (2)

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.

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.

Device: whole body hyperthermia

Interventions

whole body hyperthermia DEVICE

heat will be applied to the participant through a sauna to increase core body temperature

sham whole body hyperthermia; verum whole body hyperthermia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maren Nyer, PhD

CONTACT

6072796290; mnyer@mgh.harvard.edu

David Mischoulon, MD, PhD

CONTACT

dmischoulon@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: Subjects will be randomized to one of two WBH groups.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 5, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)