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| Column | Value |
|---|---|
| Trial registration number | NCT05630040 |
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Full text link
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 24, 2023, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : June 24, 2023, midnight Source : ClinicalTrials.gov |
None |
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Registration date
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
2022-11-29 |
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Recruitment status
Last imported at : June 24, 2023, midnight Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Crossover |
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Masking
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
inclusion criteria: provision of signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study at least 18 years of age clinical diagnosis of dysautonomia following an acute covid-19 infection at least 3 months prior. see below for criteria: clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider 2 or more if the following clinical assessment findings symptomatic exacerbation during active stand test tachycardia on active stand test tachycardia on orthostatic vitals assessment hypotension on orthostatic vitals assessment hypertension in orthostatic vitals assessment symptom exacerbation on orthostatic vitals assessment english speaking |
|
Exclusion criteria
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
• pregnancy or lactation: pregnant persons will not be included in this study for the following reasons: there is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (pcd). the results could be skewed due to pregnancy. of note, there are no risks for pregnant persons to participate. according to the device manufacturer, the following contraindications will be followed during the screening process: patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (chf), known severe coronary artery disease or recent myocardial infarction (within 5 years) patients with diagnosed bradycardia patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) patients diagnosed with narrowing of the arteries (carotid atherosclerosis) patients whose pain syndromes are undiagnosed pediatric patients pregnant women |
|
Number of arms
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Icahn School of Medicine at Mount Sinai |
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Inclusion age min
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
40 |
|
primary outcome
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Composite Dysautonomia Symptom Score (COMPASS 31);Composite Dysautonomia Symptom Score (COMPASS 31);Composite Dysautonomia Symptom Score (COMPASS 31);Composite Dysautonomia Symptom Score (COMPASS 31);Composite Dysautonomia Symptom Score (COMPASS 31) |
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Notes
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 903, "treatment_name": "Non-invasive vagus nerve stimulator", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |