Cleveland Clinic Sleep Study Overview
A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children with ASD and Sleep Disturbance
Co-PIs: Thomas W. Frazier, PhD &Jyoti Krishna, MD
Co-I’s: Leslie Speer, PhD, NCSP & Sally Ibrahim, MD
While sleep disturbance is common in typically-developing children, clinical and population studies indicate that children with autism exhibit elevated rates of sleep disturbance, including significant problems with bedtime resistance, sleep onset latency, nighttime awakenings, total sleep time, early awakenings, and other measures of sleep quality and disturbance. Sleep difficulties appear to begin early, by at least 30 months, and continue through childhood for many ASD-affected children. The presence of sleep problems in children with ASD is associated with greater daytime internalizing and externalizing behavior problems and causes significant parental stress.
Sleep disturbance etiology is not clear for all cases of ASD. However, some cases show obvious behavioral factors that maintain difficulties, there may be an increased incidence in regressive ASD, and there are several leads as to neurobiological factors that may contribute to various different types of sleep disturbance. Environmental factors and sleep hygienerelated issues have been frequently noted in the literature. Furthermore, sleep disturbances appear to be at least partially independent of sex, race/ethnicity, presence of epilepsy, and large family sizes. Treatment approaches have included behavioral treatments and environmental modifications, melatonin, and psychopharmacologic treatments. However, the evidence of efficacy and long-term effectiveness of these approaches remains limited and no group efficacy studies have identified treatments that are completely effective for all ASD-affected children with sleep difficulties. Given the high prevalence of sleep disturbance in this population, there is a great need to identify additional treatments that may improve sleep in children with ASD.
Therefore, the purpose of the present study is to evaluate the tolerability and efficacy of a new mattress technology, the Sound to Sleep SystemTM, that provides a unique sensory experience (mattress vibrations that accompany and sync with music or other auditory stimulation) designed to improve sleep quality in individuals with autism spectrum disorder and sleep disturbance. The study uses a single-blind (investigator blind not caregiver), 4-week, cross-over design to investigate the tolerability and efficacy of mattress technology in improving sleep quality and duration in children with ASD and sleep difficulties. Individuals will be randomized to receive the mattress technology (active treatment) during the first two weeks or the second two weeks of a continuous month-long period of careful monitoring of sleep and behavioral parameters. In weeks where the mattress technology is not being used, the technology will be embedded in the mattress but not turned on (placebo condition).
For this trial, the primary safety outcome measure will be drop-out due to problems with mattress technology-related tolerability. Secondary tolerability measures will include: drop-out due to any reason, sleep-related side effects, and caregiver ratings of ease-of-use. The primary efficacy outcome will be sleep impairment as rated by a blinded clinician. Secondary efficacy outcome measures will include: caregiver-rated total sleep problems, total sleep time, sleep quality, number of awakenings, sleep onset difficulties, daytime challenging behavior, autism symptom severity, other child behavior problems, sensory symptoms, child and family quality of life; clinician-rated sleep improvement; and actigraphy-based measures of latency to sleep, total sleep time, sleep efficiency, and nighttime awakenings. The study will also explore whether use of mattress technology improves measures of social attention derived from remote eye tracking during viewing of static and dynamic images and the level of correspondence between.caregiver-reported and actigraphy-computed total sleep time.