Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Chronic Fatigue Syndrome (CFS) is a prevalent, debilitating, and poorly understood condition that contributes to impaired functioning and increased health care utilization. The vast majority of CFS patients complain of unrelenting sleep disturbances (e.g., sleep onset insomnia and/or sleep maintenance insomnia) that could exacerbate symptoms such as fatigue, mood disturbance, and reduced quality of life. Research with normal sleepers and insomnia sufferers has demonstrated that sleep disruption adversely affects those systems hypothesized to be important in CFS (e.g., neuroendocrine and autonomic systems). Insomnia appears to be a perpetuating factor in CFS, as insomnia appears to develop as a comorbid condition that interacts with and worsens CFS. Perhaps because the insomnia of CFS patients traditionally has been viewed as a secondary symptom rather than as a comorbid disorder, the sleep-specific treatment needs of CFS patients have been largely ignored. In fact, there have been few studies conducted to test sleep-focused therapies with CFS patients. Both our clinical observations and our preliminary studies suggest that those with CFS display sleep targets (i.e., increased time-in-bed, decreased daytime activity) that are common to those with Primary and other comorbid insomnias. These phenomena are known to perpetuate sleep problems, and likely account for the chronic insomnia among CFS patients. Given the high prevalence and cost associated with CFS, as well as its complex clinical picture, interventions that directly address perpetuating mechanisms would likely improve the sleep and general prognosis for these patients.

The proposed randomized clinical trial will allow us to test the effects of CBT for Insomnia on sleep and waking functions among CFS patients. Positive results could lead to enhanced CFS outcomes by treating the comorbid insomnia effectively.

The consent form for this study will provide participants with information about who will provide their care during the study, the purpose of the study, the number of participants expected in the study, what is required of participants in the study, information about random assignment to study groups, how long participation in the study will last, the risks associated with the study, possible benefits of participation, alternatives for treatment other than participation in this study, information about confidentiality, costs to the participants associated with the study, compensation for participation, and who to contact if there questions about the study or injuries related to the study, the right to stop participating and withdraw from the study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00540254
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2007
Completion date July 2010

See also
  Status Clinical Trial Phase
Recruiting NCT05454683 - Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome N/A
Completed NCT01686074 - Motor Control in Chronic Fatigue Syndrome and Fibromyalgia N/A
Completed NCT02075489 - Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans N/A
Completed NCT01651754 - Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome N/A
Active, not recruiting NCT00071162 - Genetics of Fibromyalgia N/A
Withdrawn NCT04870476 - Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Recruiting NCT04542161 - Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Recruiting NCT03807973 - Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. Phase 1
Recruiting NCT05719493 - Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +) N/A
Recruiting NCT05967052 - Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation Phase 2
Terminated NCT01730495 - Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome Phase 2
Completed NCT01156909 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Phase 2
Completed NCT01650636 - Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process N/A
Completed NCT01046370 - A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia N/A
Completed NCT00100412 - Hyporeactivity and Gulf War Illness N/A
Recruiting NCT06128967 - A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial Phase 3
Completed NCT02669212 - Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health N/A
Not yet recruiting NCT06011135 - Exploring Worry in CFS/ME
Completed NCT03844412 - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments Phase 2