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

Completed · Not applicable

Conditions studied: Autism Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT02739321

Run by

The Cleveland Clinic

People needed

45

Starts

2014-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-11-06

Who can join

Age: 3 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Center for Autism — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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