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

Autism Spectrum Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739321
• Other study ID #: 14-066
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: October 3, 2017
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Center for Autism	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Kugona LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology	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.	up to 6 weeks
Secondary	Parent Reported Quality of Sleep Across Treatment Conditions	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"	Average daily score, across up to 2 weeks
Secondary	Total Time Asleep Recorded by Actigraphy Watch	Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch	Average of daily measure, across up to 2 weeks
Secondary	Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch	Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions	Average of daily measure, across up to 2 weeks
Secondary	Total Time Awake During Night Recorded by Actigraphy Watch	Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions	Average of daily measure, across up to 2 weeks
Secondary	Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.	Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.	Average of daily measure, across up to 2 weeks
Secondary	Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)	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.	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)	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.	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Communication Problems as Measured by the CCC-2	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.	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Problems With Sleep Habits as Measured by the FISH	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).	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)	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).	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ	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.	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire	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.	Baseline, 2 weeks, 4 weeks
Secondary	Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary	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	Average of daily measure, across up to 2 Weeks
Secondary	Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary	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).	Average of daily measure, across up to 2 Weeks
Secondary	Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary	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).	Average of daily measure, across up to 4 Weeks
Secondary	Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary	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).	Average of daily measure, across up to 2 Weeks
Secondary	Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary	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.	Average daily measure, across up to 2 Weeks