Depression Clinical and Research Program
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Location contact
David Mischoulon, MD, PhD
CONTACT
Maren Nyer, PhD
CONTACT
Maren Nyer, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05931497
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Location status: Recruiting
David Mischoulon, MD, PhD
CONTACT
Maren Nyer, PhD
CONTACT
Maren Nyer, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
heat will be applied to the participant through a sauna to increase core body temperature
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Contact information is provided by the study sponsor or research team.
David Mischoulon, MD, PhD
CONTACT
Maren Nyer, PhD
CONTACT
Massachusetts General Hospital
Other
A Pilot Study of Whole Body Hyperthermia for Long Covid or Post-Acute Sequelae of COVID-19 (PASC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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