Dec. 12, 2001 The Sleep Disorders Center at Rush-Presbyterian-St. Luke's Medical Center is participating in a nationwide clinical research study to explore a potential treatment for chronic Shift Work Sleep Disorder (SWSD), a condition that affects at least 70 percent of the more than 15 million Americans classified as shift workers by the U.S Bureau of Labor Statistics.
The study will attempt to determine whether the drug modafinil, which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness associated with narcolepsy, can effectively treat excessive sleepiness, improve alertness and overall function in night shift workers with chronic SWSD.
Those most likely to be affected by SWSD are individuals who work between the hours of 10:00 p.m. and 8:00 a.m. (night shift workers) and female shift workers with children in the home. Working during the night and sleeping during the day is contrary to the body's natural circadian rhythms - the body's internal "sleep clock." Symptoms of SWSD include excessive sleepiness, insomnia, headaches and difficulty concentrating, leading to on-the-job safety issues and impacting workers' quality of life.
According to the U.S. Department of Labor, 10 percent of all companies operate around the clock, forcing many workers to put in long hours and work odd schedules.
The effects of SWSD can range from mildly annoying to potentially deadly. Excessive sleepiness associated with SWSD can increase the risk for work-related injuries, and equipment and automobile accidents. In fact, studies suggest that 20-30 percent of individuals working non-traditional work schedules have had a fatigue-related driving mishap within the last year.
Additionally, sleep-deprived individuals have a tendency to get sick more frequently than well-rested peers, and are at greater risk for high blood pressure, weight gain and gastrointestinal problems. Together, these factors can result in increased sick days and decreased job productivity.
"Many shift workers have had to rely on caffeine, untested herbal remedies or self-medication with prescription drugs not indicated for this condition to control their chronic sleepiness," says James Wyatt, PhD, a sleep researcher in the Sleep Disorders Center, Rush-Presbyterian-St. Luke's Medical Center. "This study will help us determine if this investigational medication may be a better solution to improve shift workers' alertness, work function, quality of life and sleep."
Wyatt said that modafinil is generally well tolerated and when side effects do occur, they are usually mild and manageable. In clinical research trials, the most common adverse events reported were headache, nausea, infection, nervousness, anxiety and insomnia.
Men and women who have either been diagnosed with chronic SWSD, or who experience excessive sleepiness associated with working night shifts can call 1-877-NITE-JOB (1-877-648-3562) to find out if they are eligible to participate in this clinical research trial.
The study is sponsored by Cephalon, Inc., headquartered in West Chester, Pennsylvania, an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat sleep and neurological disorders, cancer and pain.
Rush-Presbyterian-St. Luke's Medical Center encompasses the 824-bed Presbyterian-St. Luke's Hospital (including Rush Children's Hospital), the 110-bed Johnson R. Bowman Health Center and Rush University. Rush University, which today has 1,271 students, is home to Rush Medical College, one of the first medical schools in the Midwest. It also includes one of the nation's top-ranked nursing colleges, the Rush College of Nursing, as well as the College of Health Sciences and the Graduate College, which offer graduate programs in allied health and the basic sciences. Rush is noted for bringing together patient are and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness neurological disorders and diseases associated with aging. The medical center is also the tertiary hub of the Rush System for Health.
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