A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorders
- Sponsor
- The Cleveland Clinic
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Thomas W. Frazier, Ph.D
Thomas W. Frazier, Ph.D
The Cleveland Clinic
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
Outcomes
Primary Outcomes
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
Time Frame: up to 6 weeks
Compare percentage of drop-out, in this cohort, due to issues with the mattress technology (e.g. ease of use, inability to fall asleep) to a population expected drop-out rate of 30% using a one-sample proportion test.
Secondary Outcomes
- Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.(Average of daily measure, across up to 2 weeks)
- Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary(Average of daily measure, across up to 4 Weeks)
- Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Problems With Sleep Habits as Measured by the FISH(Baseline, 2 weeks, 4 weeks)
- Parent Reported Quality of Sleep Across Treatment Conditions(Average daily score, across up to 2 weeks)
- Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch(Average of daily measure, across up to 2 weeks)
- Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary(Average of daily measure, across up to 2 Weeks)
- Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary(Average of daily measure, across up to 2 Weeks)
- Total Time Asleep Recorded by Actigraphy Watch(Average of daily measure, across up to 2 weeks)
- Total Time Awake During Night Recorded by Actigraphy Watch(Average of daily measure, across up to 2 weeks)
- Caregiver-Rated Communication Problems as Measured by the CCC-2(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary(Average daily measure, across up to 2 Weeks)
- Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire(Baseline, 2 weeks, 4 weeks)
- Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary(Average of daily measure, across up to 2 Weeks)