Whole-Body Hyperthermia for Mood and Anxiety Disorders
This study is looking at how whole-body hyperthermia (using a special sauna called the Clearlight dome sauna) might help people with mood and anxiety disorders, especially postpartum depression (depression after childbirth). Researchers want to understand the scientific reasons why this treatment might work. You could be eligible to join if you are between 18 and 50 years old. The study is looking for healthy adults, healthy women or transgender men who recently gave birth, and women or transgender men who recently gave birth and have postpartum depression. To see if the treatment is working, researchers will measure changes in your brain activity using an EEG (electroencephalogram) during the sauna session. The study is currently recruiting 240 participants.
- Study design
- This interventional study plans to enroll 240 participants across four groups to understand the mechanisms of whole-body hyperthermia.
- What's involved
- Participants will receive whole-body hyperthermia using a sauna until their body temperature reaches 38.5 C (101.3 F) or for up to 140 minutes. An fMRI (functional magnetic resonance imaging) will also be used to take images of the brain.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in brain activity (EEG) will be measured during the intervention session.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06144294
Whole-Body Hyperthermia for Mood and Anxiety Disorders
Not Yet Recruiting
NAAges 18–50InterventionalBasic scienceWeill Medical College of Cornell UniversityInvestigator-initiated
~240 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Whole-Body HyperthermiafMRI
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change in EEG amplitude.
Measured over During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Lauren M Osborne, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
- Jonathan Power, MD, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Group 2
Arm 1: Healthy women or transgender men 18-50 years of age, ≤ 6 months postpartum
Arm 2: Women and transgender men 18-50 years of age, ≤ 6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI.
Arm 3: Healthy adults of both sexes 18-50 years of age.
Arm 4: Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the Mini International Neuropsychiatric Interview (MINI)
Group 2: Sub-study
Exclusion
For logistics, we will exclude individuals with BMI \>30 and waist size \> 35, who may not fit comfortably in the sauna dome for all cohorts described above.
For contraindications to hyperthermia, we will exclude from all cohorts listed above, individuals with severe cardiovascular disease, including congestive heart failure, coronary artery disease, uncontrolled hypertension, and hypotension; pregnancy; active substance use disorders; recent major injuries or surgeries (\<1 week prior); impaired sweating (those with multiple sclerosis, diabetes mellitus with neuropathy, central nervous system disease, heat insensitivity); a history or family history of malignant hyperthermia, fever or active signs of infection; taking medications that may have interactions with hyperthermia (for example, barbiturates, diuretics, and beta blockers) and the use of an antipyretic or anihistamine medication in the 12 hours prior to the WBH intervention. Individuals with above mentioned conditions will be excluded since either WBH might deteriorate their conditions or it is unknown how their condition will be affected by WBH.
For contraindications to immune analyses, we will exclude individuals with conditions that might affect immune analyses, including individuals with known active autoimmune or endocrine disease and individuals with active infection at baseline.
Group 2
Arm 1: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
Arm 2: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
Arm 3: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
Arm 4: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
Group 2 and Group 2: Sub-study - All participants
For contraindications to use of the e-Celsius capsule that will be used to measure core temperature, we will exclude individuals with pacemakers or any other electric medical implant, individuals with a current intestinal disorder that could lead to obstruction of the digestive tract including gastroparesis, individuals with history of diverticula, individuals with history of past surgical procedures in the gastrointestinal tract, individuals with a swallowing disorder and individuals with Crohn's disease.
Study Group 3 - All participants
For contraindications to MRI, individuals with metal in the body will be excluded from participating in the MRI portion of the research since magnetic fields in MRI scanners can cause dangerous interactions in patients with metallic foreign bodies: projectile effect, twisting, burning, artifacts, and device malfunction (interference with a pacemaker).
What this trial measures
- Percent change in EEG amplitude.During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.
Measure the extent of broad-band neural suppression in WBH.
- Percent change in EEG frequency.During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed.
Measure the extent of broad-band neural suppression in WBH,