SBIR-STTR Award

This project addresses sleep disorders in pediatrics by developing a miniaturized, light-weight Motionlogger Actigraph for activity monitoring. Previous studies have demonstrated the value of activity monitoring in sleep disorder determination. The sleepless child needs proper diagnosis based on accurate sleep/wake data for guidance in parental education. Pilot studies have demonstrated the feasibility and value of collecting objective data from infants or children independently from parents' reports, which data provides evidence to re-schedule the child's sleep time and educate parents with proof of efficacy of treatment; and a smaller, lightweight unit would be more suitable for use with infants and small children. In Phase I a lightweight, smaller Motionlogger Actigraph with more memory will be fabricated and validated; and actigraphic data will be compared to time lapse video monitoring in a home setting in cooperation with the Sleep Research Center at Bradley Hospital (Brown University). In Phase II software and equipment will be validated with a large patient population in the home setting. Normative data will be collected on children and adolescents.

We will perform validation, testing, software development, and technical innovation for a commerially acceptable pediatric ativity monitoring instrument. A user-friendly software package will be developed for the set up of device, data recovery, data presentation, data editing, and statistical analysis, as well as pediatric clinial report, which will be generated from the colleted data. A user manual will include representative examples of tracings for the varied population selected for monitoring along with normative ranges. One-week recordings will be colleted in 50 children (50/50, male/female and a representative racial distribution) at ages 6, 12, 18, 24, 30, 36, 48 and 60 months. Thus, a total of 400 children will provide a normative database of actigraphy. Validation of sleep/wake staging will be completed on a subsample of children at ages 12, 36 and 60 months. Clinial cases will be acquired as available from local populations.Awardee's statement of the potential commercial applications of the research:Continuous actigraphic monitoring of sleep disturbed children offers an opportunity to the pediatric medical community to document sleep patterns in the child's home in comparison with a well documented normative sample.National Institute of Mental Health (NIMH)