Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Completed · Not applicable · Has a placebo group
Conditions studied: Down Syndrome, Obstructive Sleep Apnea Syndrome
In brief
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.
Key facts
- Study ID
- NCT01808508
- Run by
- Children's Hospital of Philadelphia
- People needed
- 27
- Starts
- 2010-09-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-02-08
Who can join
Age: 8 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 8-20 years
- Down syndrome (based on the characteristic phenotype)
- Families provide informed consent and child provides assent
You may not qualify if…
- Subjects and families who do not speak English well enough to undergo psychometric testing.
- Subjects living in institutions where there is no primary caregiver to participate in the neurocognitive/behavioral battery.
- Major chronic lung disease such as chronic aspiration.
- Previous or current CPAP therapy.
- Participation in a weight loss program.
- Craniofacial or neuromuscular conditions other than those associated with DS.
- Untreated hypothyroidism. Participants with normal thyroid function tests will be included in the study.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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