Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT04859257
Eligibility Criteria:
Inclusion Criteria: (Cohort 1)
1. Male and female patients age 18 or older at the time of consent
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide unassisted informed consent
5. Medical Record Consent (optional)
6. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR
7. Report experiencing one or more of the following symptoms (record all that apply):
1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
5. Worsening of symptoms while standing or sitting upright -
Exclusion Criteria:
* Pregnancy
Inclusion Criteria: (Cohort 2)
1. Male and female patients age 18 or older at the time of consent
2. Have a permanent address in the United States for the duration of the study
3. Have an email address and access to the internet for the duration of the study
4. Able to provide unassisted informed consent
5. Medical Record Consent (optional)
Exclusion Criteria:
1. Pregnant
2. Diagnosed with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) OR
3. Report experiencing one or more of the following symptoms (record all that apply):
1. Greatly lowered ability to perform normal daily activities due to profound fatigue that has lasted for at least 6 months
2. Worsening of (fatigue) symptoms after physical or mental activity that would not have caused a problem before illness (post-exertional malaise).
3. Sleep Problems. Feel overly tired or unrefreshed even after a full night of sleep
4. Problems with thinking and memory (trouble thinking quickly, remembering things, paying attention to details, have "brain fog") OR
5. Worsening of symptoms while standing or sitting upright
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04859257
Study Brief:
Protocol Section:
NCT04859257