A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Months 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Mattress Technology On then Off
Intervention: Sound to Sleep System will be turned on for the first two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration.
No intervention: The mattress technology will be turned off for the second two weeks of the study. During this time, there will be no intervention.
干预措施: Sound to Sleep System (Device)
Mattress Technology Turned Off then On
No intervention: For the first two weeks of the study, the mattress technology will not be turned off. There will be no intervention during this time.
Intervention: Sound to Sleep System will be turned on for the second two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration.
干预措施: Sound to Sleep System (Device)
结局指标
主要结局
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
研究者
Thomas W. Frazier, Ph.D
Thomas W. Frazier, Ph.D
The Cleveland Clinic