ME/CFS: Activity Patterns and Autonomic Dysfunction

Status unconfirmed

Conditions studied: Chronic Fatigue Syndrome

In brief

The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four year study would be the first to look at the relation between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.

Key facts

Study ID

NCT02948556

Run by

Stony Brook University

People needed

150

Starts

2016-06-01

Expected to finish

2020-05-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fukuda-based ME/CFS symptoms including:
• six months of unexplained, debilitating fatigue
• 4/8 secondary symptoms impaired memory or concentration unrefreshing sleep sore throats headache muscle pain joint pain tender lymph nodes post-exertional malaise

You may not qualify if…

• Medical: fatigue clearly attributable to self-report medical conditions.
• Psychiatric any psychosis alcohol/ substance abuse within two years prior or after illness onset. depression with melancholic/psychotic features within 5 years of onset .
• Two other exclusionary criteria:
• patients not dose-stabilized for at least 3 months on antidepressants ;
• patients at risk of suicide or need of urgent psychiatric treatment.

Where it is running

• Stony Brook University — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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