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

NCT ID: NCT02739321

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism; ASD; Sleep; Mattress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sound to Sleep System

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Sound to Sleep System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kugona LLC

UNKNOWN

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Thomas W. Frazier, Ph.D

Thomas W. Frazier, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Frazier, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Center for Autism

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

14-066

Identifier Type: -

Identifier Source: org_study_id