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NCT01808508 · ClinicalTrials.gov registry record · NA
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
A NA study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT01808508: Completed NA study, sponsored by Children's Hospital of Philadelphia.
NCT01808508 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808508, a NA study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE Continuous positive airway pressure
- DEVICE Sham or placebo continuous positive airway pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT01808508 record still lists
NCT01808508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Continuous positive airway pressure is the first listed.
NCT01808508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01808508 about?
NCT01808508 is a clinical study titled "Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome". 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 hea...
What is the current status of trial NCT01808508?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2010-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01808508?
The interventions under investigation include: Continuous positive airway pressure (DEVICE), Sham or placebo continuous positive airway pressure (DEVICE).
Who is sponsoring clinical trial NCT01808508?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01808508's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 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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