Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome
Completed · Not applicable
Conditions studied: Chronic Fatigue Syndrome
In brief
The objective of this study is to measure sympathetic nervous system function and stress responses in patients with clinically documented and self-reported chronic fatigue that is worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS) and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress.
Key facts
- Study ID
- NCT03029377
- Run by
- Vanderbilt University Medical Center
- People needed
- 55
- Starts
- 2017-01-01
- Expected to finish
- 2018-02-23
- Last updated by the study team
- 2018-04-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Confirmed chronic fatigue with severity >50 on a scale of 1 to 100 that is not improving over time
- Meet The Centers for Disease Control and Prevention (CDC) diagnostic criteria of CFS (self-reported persistent or relapsing fatigue lasting 6 or more consecutive months)
You may not qualify if…
- Male and female subjects <18 or >60 years
- Obesity, defined as a BMI of 30 or more
- Presence of other medical or psychiatric conditions known to cause fatigue (alcohol/drug abuse, anorexia nervosa, bipolar disorder, bulimia nervosa, dementia, major depression, psychotic/delusional disorders, schizophrenia)
- Presence of sleep disorder/disruption known to cause fatigue (sleep apnea, narcolepsy)
- Cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing defined as significant by investigator (including but not limited to chronic hepatitis, chronic kidney disease, cirrhosis, emphysema, heart failure, HIV, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis)
- History of hypertension defined as supine resting BP>145/95 mmHg off medications or needing antihypertensive medication
- Patients taking medications that can affect autonomic function or plasma catecholamines (vasoactive drugs), stimulants, and/or are sedatives
- Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
- Inability to stand unassisted for 10 minutes
- Patients who are bedridden or chair-ridden
- Patients who are colorblind
- Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- Patients who are pregnant or breastfeeding
- Healthy Control Participants:
- Participant with no significant reported conditions or medications.
- Exclusion Criteria:
- Male and female subjects <18 or >60 years
- Obesity, defined as a BMI of 30 or more
- Presence of any serious or chronic disease, or prescription medication as deemed by investigator including hypertension as defined by supine resting BP >145/95 mmHg off medications or needing antihypertensive medication
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
- Inability to stand unassisted for 10 minutes
- Patients who are bedridden or chair-ridden
- Patients who are colorblind
- Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- Patients who are pregnant or breastfeeding
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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