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

NCT02739321 | Completed Results

• 1 other identifier: 14-066
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism; ASD; Sleep; Mattress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Parent Reported Quality of Sleep Across Treatment Conditions

  Average daily score, across up to 2 weeks

• Total Time Asleep Recorded by Actigraphy Watch

  Average of daily measure, 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

• 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

Study Arms (2)

Mattress Technology On then Off

EXPERIMENTAL

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.

Device: Sound to Sleep System

Mattress Technology Turned Off then On

EXPERIMENTAL

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.

Device: Sound to Sleep System

Interventions

Sound to Sleep System DEVICE

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.

Mattress Technology On then Off; Mattress Technology Turned Off then On

Eligibility Criteria

• Age: 30 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASD Diagnosis
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Kugona LLC: collaborator

Study Sites (1)

Cleveland Clinic Center for Autism

Cleveland, Ohio, 44104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Thomas Frazier
• Organization: The Cleveland Clinic

fraziet2@ccf.org

Study Officials

• Thomas Frazier, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas W. Frazier, Ph.D

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: April 15, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)