Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD

The present study aims to evaluate the tolerability and efficacy of a new mattress technology
in improving the sleep quality of children with Autism Spectrum Disorder (ASD). Clinical and
population studies indicate that children with ASD exhibit elevated rates of sleep
disturbance compared to their typically-developing peers and that 50% to 80% of children with
ASD have sleep problems. Sleep disturbance can include bedtime resistance, sleep onset
latency, nighttime awakenings, decreased total sleep time, early morning awakenings, and
other measures of sleep quality. Sleep problems in children with ASD are associated with
greater externalizing and internalizing behavior problems during the waking day, poorer
adaptive functioning, and can cause significant parental stress. Previous studies have
examined the effectiveness of behavioral treatments, environmental modifications, melatonin,
and psychopharmacologic treatments in decreasing the rates of sleep disturbance. However,
none of these approaches have identified treatments that are 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.

The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To
Sleep System™ using a single blind (actigraphy scoring blinded), cross-over design. The Sound
To Sleep System™ is a mattress foundation designed to improve sleep quality in individuals
with ASD and sleep disturbance by providing mattress vibrations that accompany and sync with
auditory stimulation. For the present study, the primary objectives are as follows:

SA1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected children
with sleep disturbances is well tolerated as defined by group drop-out proportion due to
issues with the mattress technology.

The study will also explore the following objectives:

SA2 - To determine the efficacy of the Sound To Sleep System™ in improving parent-reported
sleep quality in ASD-affected children with sleep disturbances.

SA3 - To determine the tolerability of the Sound To Sleep System™ as defined by study
drop-out due to any reason and caregiver ratings of ease of mattress technology use.

SA4 - To determine whether use of the mattress technology improves functioning as defined by
secondary outcome measures.

Inclusion Criteria:

- ASD Diagnosis

- 2.5-12.99 Years of Age

- Sleep Difficulty as indicated by significant sleep disturbance on the Child Sleep
Habits Questionnaire

- If participant is using medication or attends therapy, it must be stable four (4)
weeks prior to their study participation and throughout the 5-6 week study period.

Exclusion Criteria:

- Age less than 2.5 years or more than 12.99 years

- Individuals who may have medication or therapy changes 4 weeks prior to study start
date or during the study period

- An participant diagnosed with epilepsy, Fragile X, Downs Syndrome, seizure disorder,
Neurofibromatosis, or Tuberous Sclerosis

- Any child with a pacemaker or other electrical device