CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Continuous positive airway pressure +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01808508
NCT01808508N/ACompleted

Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome

Children's Hospital of Philadelphia·interventional·Posted Mar 11, 2013·Updated Feb 8, 2016

In Brief

A clinical study evaluating Continuous positive airway pressure and Sham or placebo continuous positive airway pressure for Down Syndrome and Obstructive Sleep Apnea Syndrome. Completed, enrolled 27 participants across 1 site.

Detailed Summary

Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down syndrome because of the shape of their face and tongue and because of their low muscle tone. OSAS can cause a lot of health problems including behavioral and learning problems as well as heart problems. The purpose of this research study is to look at the effects of treating OSAS in individuals with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The investigators want to see if treatment of OSAS improves learning, behavior and heart problems.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2013
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.3 years ago

Interventions

Continuous positive airway pressuredevice

Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open.

Sham or placebo continuous positive airway pressuredevice

Sham or placebo CPAP is a machine used instead of therapeutic CPAP. This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS.