Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To
      Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD).
      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:

      * Study Aim 1 - 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:

        -  Study Aim 2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep
           quality as measured by parent reported sleep quality in ASD-affected children with sleep
           disturbances. (Please note Study Aim 2 was changed from clinician-rated to parent-rated
           because we were not able to collect clinician-rated sleep quality information).

        -  Study Aim 3 - 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.

        -  Study Aim 4 - To determine whether use of the mattress technology improves functioning
           as defined by secondary outcome measures.
    

Detailed description: 
      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:

      Study Aim 1- 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:

      Study Aim 2- To determine the efficacy of the Sound To Sleep System™ in improving
      parent-reported sleep quality in ASD-affected children with sleep disturbances.

      Study Aim 3- 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.

      Study Aim 4- To determine whether use of the mattress technology improves functioning as
      defined by secondary outcome measures.
    

Intervention name(s): Sound to Sleep System
Intervention type(s): Device
Intervention description(s): Sound to Sleep System is a minimal risk device that is embedded in a mattress boxspring. The device syncs with an audio input and emits tactile vibrations in sync with the audio input.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Autism; ASD; Sleep; Mattress