Crohn’s Disease and Sleep Disturbance Study – Phase IV

Protocol Description

Through this study, sponsored by the Crohn's and Colitis Foundation of America, researchers hope to better understand whether behavioral and/or medication interventions can be effective in improving sleep and reducing fatigue for patients with Crohn’s disease, a type of inflammatory bowel disease (IBD). Investigators will study types of sleep disturbances within this patient group, their frequency, and how they relate to other measures of disease. Their goal is to gain insights into new treatments to increase quality of life by improving sleep in this patient group.

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to males and females, between the ages of 15 and 30 years old, who have been diagnosed with Crohn’s disease and experience sleep disturbances or fatigue. A control group of healthy individuals will also be included.
Boys: 15 to 30 years old
Girls: 15 to 30 years old

Requirements

In the first phase, study doctors will provide behavioral therapy in self-management techniques to improve sleep, such as self-hypnosis, relaxation and reflection. Depending on their response to behavioral therapy in the first 8 weeks, participants will either continue with behavioral therapy In the second phase or will take an 8-week course of a sustained release medication to reduce fatigue, depression, and inflammation, while enhancing REM sleep. During assessments, participants wear a wrist device that records total sleep time, wakefulness, and more, and blood samples will be taken during visits. In addition, participants will maintain a sleep diary.
Visits: 6 to 8 depending on response to therapies
Duration: 16 weeks

Status: Open for Enrollment

Source(s) of Support

Crohn’s and Colitis Foundation of America

Additional Information

Crohn’s Disease
Study description at the National Institutes of Health

Primary Investigator

Eva Szigethy, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
David M. Rizzo, LCSW
412-692-3184