Clinical trial NCT02739321: Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD
Official title: A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Autism
ASD
Sleep
Mattress
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Kugona LLC
First posted: 2016-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Parent Reported Quality of Sleep Across Treatment Conditions
timeFrame: Average daily score, across up to 2 weeks
measure: Total Time Asleep Recorded by Actigraphy Watch
timeFrame: Average of daily measure, across up to 2 weeks
measure: Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch
timeFrame: Average of daily measure, across up to 2 weeks
measure: Total Time Awake During Night Recorded by Actigraphy Watch
timeFrame: Average of daily measure, across up to 2 weeks
measure: Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.
timeFrame: Average of daily measure, across up to 2 weeks
measure: Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Communication Problems as Measured by the CCC-2
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Problems With Sleep Habits as Measured by the FISH
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary
timeFrame: Average of daily measure, across up to 2 Weeks
measure: Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary
timeFrame: Average of daily measure, across up to 2 Weeks
measure: Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary
timeFrame: Average of daily measure, across up to 4 Weeks
measure: Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary
timeFrame: Average of daily measure, across up to 2 Weeks
measure: Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary
timeFrame: Average daily measure, across up to 2 Weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Autism
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Thomas Frazier, PhD
role: PRINCIPAL_INVESTIGATOR
References: