N/A Completed N=45 Randomized Single-blind Supportive Care

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

Source: ClinicalTrials.gov NCT02739321 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcomePrimary: Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology — 1; 1 Participants — p=<.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology	1; 1	<.001 sig
SECONDARY Parent Reported Quality of Sleep Across Treatment Conditions	4.9; 4.3	.001 sig
SECONDARY Total Time Asleep Recorded by Actigraphy Watch	8.35; 7.99	0.001 sig
SECONDARY Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch	14.11; 18.20	.268
SECONDARY Total Time Awake During Night Recorded by Actigraphy Watch	17.85; 18.79	.058
SECONDARY Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.	78.27; 75.45	.001 sig
SECONDARY Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)	76.40; 73.68; 74.77	.232
SECONDARY Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)	56.9; 48.61; 55.37	0.100
SECONDARY Caregiver-Rated Communication Problems as Measured by the CCC-2	48.31; 52.31; 50.79	0.285
SECONDARY Caregiver-Rated Problems With Sleep Habits as Measured by the FISH	46.82; 48.79; 47.15	0.089
SECONDARY Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)	56.53; 49.13; 52.66	0.040 sig
SECONDARY Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ	124.58; 129.43; 125.49	0.471
SECONDARY Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire	79.95; 84.54; 79.87	0.015 sig
SECONDARY Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary	4.73; 4.35	0.001 sig
SECONDARY Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary	5.61	—
SECONDARY Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary	5.51	—
SECONDARY Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary	6.04	—
SECONDARY Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary	4.28; 4.79	.001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02739321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.