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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
heat will be applied to the participant through a sauna to increase core body temperature
Depression Clinical and Research Program
Boston, Massachusetts, United States
RECRUITINGThe 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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2-weeks (primary endpoint) follow up at 6 weeks