Patient-Centered Assessment of Symptoms and Outcomes

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Study ID
NCT03952624
Status
Recruiting
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Conditions

  • CFS
  • Cancer
  • Fatigue
  • Lupus
  • ME/CFS
  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
  • Sjogrens
  • Systemic Lupus Erthematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.

Key Dates

Start date
Sep 13, 2019
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
692 participants (estimated)

Arms

  • Arm: Control
    FNS \<= 3
  • Arm: Fatigued
    FNS \>= 4

Primary Outcome Measure

Fatigue Level [ Time Frame: Stage 1 and Stage 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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