Down Syndrome Clinical Trial
Official title:
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 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.
All individuals participating in the study will be evaluated for obstructive sleep apnea
syndrome (OSAS) with a baseline sleep study. Based on the results of the sleep
study,individuals with OSAS will be randomly assigned into two groups. One group will
receive continuous positive airway pressure (CPAP) and the other intervention group will
receive sham CPAP(placebo) for four months. CPAP is a machine with a mask that fits over the
nose, is worn during sleep and helps keep the airway open. Sham CPAP (placebo) is a machine
that looks and sounds like a CPAP machine but does not give pressure so it does not treat
OSAS. Individuals with normal breathing during the sleep study will not receive a machine,
and will serve as controls.
Individuals will also have baseline tests including blood tests, an echocardiogram (pictures
of the heart), a walking test and learning tests. After 4 months, the baseline tests will be
repeated in all participants. At the end of the study, all individuals with OSAS will get
treatment.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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