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NCT02739321 · ClinicalTrials.gov registry record · NA
Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT02739321: Completed NA study, sponsored by The Cleveland Clinic.
NCT02739321 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02739321, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Sound to Sleep System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT02739321 record still lists
NCT02739321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Sound to Sleep System is the first listed.
NCT02739321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02739321 about?
NCT02739321 is a clinical study titled "Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD". 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 an...
What is the current status of trial NCT02739321?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2014-05. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02739321?
The interventions under investigation include: Sound to Sleep System (DEVICE).
Who is sponsoring clinical trial NCT02739321?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02739321's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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