Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

Completed · Phase 1/Phase 2

Conditions studied: Chronic Fatigue Syndrome, Behavioral Therapy Targeted to Sleep Problems

In brief

The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.

Key facts

Study ID

NCT00540254

Run by

Duke University

People needed

24

Starts

2007-09-01

Expected to finish

2010-07-01

Last updated by the study team

2013-03-01

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic Fatigue Syndrome and Insomnia
• meet diagnostic criteria for insomnia
• be diagnosed with CFS by the Study Physician using CDC criteria
• must be in current treatment for CFS (we can provide referrals if needed).
• under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month.
• Study patients can have comorbid depression (as long as it is not bipolar, melancholic or psychotic) or fibromyalgia. They can be taking sleep medications.

You may not qualify if…

• Those with untreated medical disorders that could account for the fatigue, or affect sleep. Medical conditions that would exclude a participant include:
• organ failure resulting from conditions such as emphysema, cirrhosis, cardiac failure, chronic renal failure
• chronic infections, including AIDS, and hepatitis B or C
• rheumatic and chronic inflammatory diseases that could account for the fatigue: including systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis
• major neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
• diseases requiring systemic treatment (e.g., organ or bone marrow transplantation, systemic chemotherapy, radiation of brain, thorax, abdomen, or pelvis)
• untreated major endocrine diseases (e.g., hypopituitarism, adrenal insufficiency)
• being on medications with known fatigue side effects or medications that have not been stable for at least one month
• inadequately-treated hypothyroidism
• untreated or unstable diabetes mellitus
• active infection
• pregnancy, 1-3 months post-partum or breast feeding
• within 6 months post-operation for a major surgical procedure
• within 3 months post-operation of minor surgery
• major infections, such as sepsis or pneumonia until 3 months post-resolution
• major conditions whose resolution may be unclear for at least 5 years (e.g., myocardial infarction, heart failure)
• terminal conditions
• severe obesity as defined as a body mass index (weight in kilograms/height in meters)2 > 40
• elective surgery planned during the trial
• We will exclude those who meet DSM-IV criteria currently or in the past 5 years for psychotic or melancholic Major Depression, bipolar disorders, schizophrenia, or eating disorders, alcohol or substance abuse or dependence (e.g., dependence on benzodiazepines or any other substance)
• We will exclude those meeting criteria for Narcolepsy, Restless Legs Syndrome, a Circadian Rhythm Disorder, or sleep apnea and/or hypopnea.
• We will exclude those with a medication change within the last month to ensure participants are on a stable dose and regimen of medication. *Once potential patients have had a stable medication regimen for > 1 month, participants can enter the trial.

Where it is running

• Duke University Medical Center - Insomnia and Sleep Disorders Lab — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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