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

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ClinicalTrials.gov Identifier: NCT02739321
Recruitment Status : Completed
First Posted : April 15, 2016
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Kugona LLC
Information provided by (Responsible Party):
Thomas W. Frazier, Ph.D, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE July 21, 2014
First Posted Date  ICMJE April 15, 2016
Results First Submitted Date  ICMJE February 13, 2017
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Compare proportion of participants who drop out of study as a measure of toleration of mattress technology [ Time Frame: up to 6 weeks ]
Compare drop-out proportion 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 proportion of 30% using a one-sample proportion test.
Change History Complete list of historical versions of study NCT02739321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Parent Reported Quality of Sleep Across Treatment Conditions [ Time Frame: Average daily score, across up to 2 weeks ]
    Within subjects comparison of the average daily, parent reported sleep quality across on and off conditions using a Likert-type scale of 1-7 in which 1 is "extremely poor" and 7 is "exceptional"
  • Total Time Asleep Recorded by Actigraphy Watch [ Time Frame: Average of daily measure, across up to 2 weeks ]
    Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch
  • Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch [ Time Frame: Average of daily measure, across up to 2 weeks ]
    Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions
  • Total Time Awake During Night Recorded by Actigraphy Watch [ Time Frame: Average of daily measure, across up to 2 weeks ]
    Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions
  • Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch. [ Time Frame: Average of daily measure, across up to 2 weeks ]
    Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.
  • Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of average Social Responsiveness Scale -2 (SRS-2) T-scores in baseline, and on and off conditions. SRS-2 T-score ranges from 30-90 (M = 50, SD = 10). Higher T-scores indicate a greater extent of social communication deficits.
  • Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the parent completed Aberrant Behavior Checklist (ABC) total raw score in the baseline, and on and off conditions. The ABC measures the level of challenging behavior of individuals in and across 5 subdomains (Irritability, lethargy, stereotypy, hyperactivity, inappropriate speech) using a Likert-type scale of 0-3 in which 0 is "not at all a problem" and 3 is "the problem is severe in degree". The sum raw scores of these subdomains make up the total ABC raw score (range = 0-174) in which a higher score indicates more severe challenging behaviors.
  • Caregiver-Rated Communication Problems as Measured by the CCC-2 [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the average Children's Communication Checklist (CCC-2) General Communication Composite standard scores across baseline, and on and off conditions. CCC-2 is a parent questionnaire that assesses children's communication skills across 10 domains using a 4-point Likert type scale (0=less than once a week/never to 3=several times a day/always). The general communication composite standard score based on age norms was used to asses overall communication competency (M=100, SD=15). Lower general communication composite scores indicate a higher likelihood of significant communication problems.
  • Caregiver-Rated Problems With Sleep Habits as Measured by the FISH [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the Family Inventory of Sleep Hygiene (FISH) average total raw scores across baseline, and on and off conditions. The FISH is a parent-completed questionnaire that assesses sleep hygiene-related behaviors in children using a 5-point Likert scale (1=Never, 2=occasionally, 3=Sometimes, 4=Usually, 5=Always). Typically parents rate these behaviors with reference to the past month, but for the present study they were asked to rate for only the previous two weeks to correspond to each mattress condition. The total raw score was used to asses sleep hygiene (Range = 12-60, in which higher scores are indicative of better sleep hygiene-related behaviors).
  • Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the Children's Sleep Habits Questionnaire CSHQ average total raw scores across baseline and on and off conditions. The CSHQ is a parent-completed questionnaire that measures a variety of sleep-related problems using a 3-point Likert-scale (1=rarely/0 to 1 times per week, 2= sometimes/2-4 times per week, 3=usually/5-7 times per week). Ordinarily, parents rate these behaviors for the pas week but for the present study they were instructed to rate for the past two weeks to correspond to the mattress on and off conditions. The total raw scores were use to evaluate overall sleep difficulties (Range = 45-135, in which a higher score is indicative of more sleep problems).
  • Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the Short Sensory Profile Questionnaire (SSPQ) average total raw scores across baseline and on and off conditions. The SSPQ is a parent-completed questionnaire that measures behaviors related to sensory processing abnormalities. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. The total raw score was used to evaluate overall sensory abnormalities (Range=38-190). Lower scores indicate a higher probability of sensory processing abnormalities.
  • Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the Child and Family Quality of Life 2 (CFQL-2), quality of life average total raw scores across baseline and on and off conditions. The CFQL-2 is a parent questionnaire that evaluation seven different aspects of child and family quality of life (child, family, caregiver, financial, partner relationship, external support, and coping quality of life). An adapted version was used that decreased the number of total items from 32 to 26 and added an additional item to each scale to specifically evaluate changes of the past two weeks in quality of life. Items use a 5-point Likert scale ranging from (1=strongly disagree/decreased substantially to 3=neutral/same to 5=strongly agree/improved substantially). The total raw score was used to evaluate overall quality of life for child and family (Range=26-130). A lower, overall score indicates a lower quality of life for the child and their family.
  • Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary [ Time Frame: Average of daily measure, across up to 2 Weeks ]
    Within subjects comparison of average challenging behavior/task compliance, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptional" in the mattress technology on and off conditions
  • Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary [ Time Frame: Average of daily measure, across up to 2 Weeks ]
    Comparison of average tolerance of mattress technology, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", in the on condition compared to the median score of 4 (average toleration of mattress technology).
  • Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary [ Time Frame: Average of daily measure, across up to 4 Weeks ]
    Comparison of average tolerance of the actigraph watch, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", across treatment conditions compared to median score of 4 (average toleration of actigraph watch).
  • Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary [ Time Frame: Average of daily measure, across up to 2 Weeks ]
    Comparison of ease of mattress technology use, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy" in mattress technology on condition to median score of 4 (average ease of use of mattress technology).
  • Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary [ Time Frame: Average daily measure, across up to 2 Weeks ]
    Within subjects comparison of average difficulty for child to go to bed, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy", in the mattress technology on and off conditions.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Parent reported quality of sleep across treatment conditions using a scale of 1-7 in which 1 is "extremely poor" and 7 is "exceptional" [ Time Frame: Daily, Up to 4 weeks ]
    Within subjects comparison of daily, parent reported sleep quality across conditions.
  • Total Time Asleep Recorded by Actigraphy Watch [ Time Frame: Daily, Up to 4 weeks ]
    Within subjects comparison of total sleep time recorded by actigraphy watch across treatment conditions
  • Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch [ Time Frame: Daily, Up to 4 weeks ]
    Within subjects comparison of sleep latency recorded by actigraphy watch across treatment conditions
  • Total Time Awake During Night Recorded by Actigraphy Watch [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of total time awake during night recorded by actigraphy watch, across treatment conditions.
  • Proportion of time in bed that the participant spent sleeping (sleep efficiency) recorded by actigraphy watch. [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of sleep efficiency recorded by actigraphy watch across treatment conditions.
  • Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of SRS-2 T-scores across treatment conditions
  • Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of ABC total raw scores across treatment conditions.
  • Caregiver-Rated communication problems as measured by the Children's Communication Checklist 2 (CCC-2) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the CCC-2 General Communication Composite standard scores across treatment conditions.
  • Caregiver-Rated problems with sleep habits as measured by the Family Inventory of Sleep Hygiene (FISH) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the FISH total raw scores across treatment conditions.
  • Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the CSHQ total raw scores across treatment conditions.
  • Caregiver-Rated sensory issues across domains as measured by the Short Sensory Profile Questionnaire (SSPQ) [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the SSPQ total raw scores across treatment conditions.
  • Caregiver-Rated of quality of life as measured by the Child and Family Quality of Life 2 (CFQL-2) questionnaire [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Within subjects comparison of the total CFQL-2, quality of life total raw scores across treatment conditions.
  • Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of challenging behavior/task compliance, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptional", across treatment conditions.
  • Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of tolerance of mattress technology, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", across treatment conditions.
  • Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of tolerance of the actigraph watch, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", across treatment conditions.
  • Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of ease of mattress technology use, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy".
  • Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary [ Time Frame: Daily, Up to 4 Weeks ]
    Within subjects comparison of difficulty for child to get to sleep, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy", across treatment conditions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 11, 2016)
Aggregate of dwell time to social and non-social regions of interest while viewing dynamic scenes and static images, as measured by SensoMotoric Instruments remote eye-gaze tracking software and hardware. [ Time Frame: Baseline, 2 Weeks, 4 Weeks ]
Within subjects comparison of Autism Risk Index score across treatment conditions
 
Descriptive Information
Brief Title  ICMJE Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD
Official Title  ICMJE A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE Device: Sound to Sleep System
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.
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Device: Sound to Sleep System
  • Experimental: 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.

    Intervention: Device: Sound to Sleep System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2017)
45
Original Actual Enrollment  ICMJE
 (submitted: April 11, 2016)
68
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739321
Other Study ID Numbers  ICMJE 14-066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas W. Frazier, Ph.D, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Kugona LLC
Investigators  ICMJE
Principal Investigator: Thomas Frazier, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP