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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole body hyperthermia | Device | heat will be applied to the participant through a sauna to increase core body temperature |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maren Nyer, PhD | Contact | 6072796290 | mnyer@mgh.harvard.edu | |
| David Mischoulon, MD, PhD | Contact | dmischoulon@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Clinical and Research Program | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Subjects will be randomized to one of two WBH groups.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2-weeks (primary endpoint) follow up at 6 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |