Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2021-08-31
2025-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Saline Infusion
Saline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Sham Infusion
Saline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Interventions
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Saline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Eligibility Criteria
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Inclusion Criteria
* Meet the 2015 IOM case definition for ME/CFS
Exclusion Criteria
* Patients taking medications that would dampen cardiac response to exercise
* Patients with psychotic illness, bipolar disorder, or current major depressive disorder
* Patients with a history of anorexia or bulimia within 5 years of intake
* Patients with a history of alcohol or drug abuse within 2 years of intake
25 Years
60 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Benjamin Natelson
Professor, Neurology
Principal Investigators
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Benjamin Natelson, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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GCO 19-1952
Identifier Type: -
Identifier Source: org_study_id