NCT01808508|CompletedResultsDMC
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
TRIO
Loading search results
Sponsor study identifier
interventional
27
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 7, 2013
Actual (reported)March 11, 2013
Actual (reported)March 2014
Actual (reported)September 2014
Actual (reported)February 8, 2016
Actual (reported)Change in Epworth Sleepiness Scale From Baseline to End of Study
The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).
4 Months
Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months
4 Months
Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months
4 Months
Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months
4 Months
Group 1 will receive therapeutic CPAP for 4 months.
Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
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 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.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
This preliminary study was limited by the small sample size, and the few children with Down Syndrome but normal breathing during sleep.
Carole Marcus, MD
Children's Hospital of Philadelphia
27 participants (actual enrollment reported by the registry).
First Submitted
March 7, 2013
First Posted
March 11, 2013
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
February 8, 2016
Results First Posted
February 8, 2016
Record last verified: 2015-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: