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Beth Malow, M.D., third from left, and melatonin study colleagues, from left, Karen Adkins, R.N., Lynnette Henderson, Ph.D., Kay Artibee, R.N., Suzanne Goldman, Ph.D., and Susan McGrew, M.D. (photo by Anne Rayner)
Investigators seek to help children with autism sleep better
Vanderbilt Sleep Disorders Center researchers are launching a study to determine if melatonin, an over-the-counter and relatively inexpensive dietary supplement taken for insomnia and jet lag, is effective in treating children with autism who have difficulty falling asleep.
Autism Speaks, in conjunction with the Dana Foundation, is contributing $100,000 over two years to support the pilot clinical trial led by Beth Malow, M.D., M.S., medical director of the Vanderbilt Sleep Disorders Center.
Melatonin is a chemical substance in the brain that promotes sleep, Malow said, and children with autism have been shown to have deficiencies with melatonin so there may be a biological reason why the supplement works. Studies have shown melatonin to be associated with minimal side effects.
The melatonin study includes a parental stress index to determine if better sleeping patterns for the children actually translate into less stress for parents.
“If a child is sleeping better, then the parents are sleeping better. They feel better about themselves and what they can do for their child during the day so it translates into things like limiting behaviors that may be counterproductive for a child,” Malow said.
“It makes the whole family unit better because the parents feel empowered and they have a sense of control over their child's sleep and behavior.”
Malow, also a Vanderbilt Kennedy Center investigator, said very few sleep studies have been conducted on children with autism, in part because mainstream thinking has been that the experience would be too overwhelming due to tactile sensitivities.
“If little tags bother them on their clothes how could you possibly put electrodes on them?” said Malow, who published her latest autism sleep research in the December issue of the journal SLEEP.
“But we found a high degree of success in doing these studies. The key was having child-friendly sleep technologists who made the experience fun for the child, providing sticker books and other rewards.”
Research coordinator Karen Adkins, R.N., said home visits to help the child and parents get accustomed to the sleep study experience have also been successful.
“The parents prepare their child with a story book illustrated with photos of children having sleep studies,” she said.
Malow's research has concluded that some children with autism sleep better than others and the good sleepers have better behavioral measures, which opens the door to a realm of possibilities. Her group is also recruiting for a parental education/behavioral techniques sleep study that doesn't involve medication, which will coincide with the melatonin study.
“We really don't want to limit inclusion, either in our study or down the road. We don't want to make it sound like you have to take medicine because there are alternatives,” she said.
“In our sleep clinics, we start with behavioral therapy before we give an adult or a child medication. We start with sleep habits and good sleep practices because it is always best to avoid medicine for any condition. Even if it's a benign supplement like melatonin it is always a good idea.”
Together the two studies will serve as the foundation for a large, federally funded multi-center trial.
Adkins said the Sleep Center is currently seeking 20 children with autism whose parents report sleep disorders are a major problem to participate in the melatonin study, and 30 children for the parental education/behavioral techniques study.
The parental education study will require a total of five visits — a pre-assessment, three sessions of education, and a post-assessment.
The melatonin study is seeking participants who are medication-free and seizure-free. It requires weekly contact with the parents over the phone or via e-mail and at least six visits to Vanderbilt during a 17-week period.
Parents will record their child's sleep patterns through "sleep diaries,” their child's behavior and parental stress levels. Then, parents will begin giving their child liquid melatonin in gradually increased doses.
Children will wear activity meters (watch-like devices) on their wrists that quantify movement and rest as a surrogate for wakefulness and sleep. Through the pilot study, the researchers will determine optimal dose, timing, and safety and tolerability of melatonin, and determine any needed modifications in the behavioral and stress scales to be used in the anticipated randomized clinical trial.
Malow's collaborators include Susan McGrew, M.D., assistant professor of Pediatrics; Wendy Stone, Ph.D., professor of Pediatrics and director of Vanderbilt's Treatment and Research Institute for Autism Spectrum Disorders; and Lynnette Henderson, Ph.D., research assistant professor of Pediatrics.
A total of 12 studies were selected nationwide through a competitive grant process that allocated $1.2 million to stimulate new approaches to understanding, diagnosing and treating autism.
For more information contact Karen Adkins at 936-1646 or e-mail autismsleepresearch@vanderbilt.edu.