Status:
COMPLETED
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Down Syndrome
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Aged 8-20 years
- Down syndrome (based on the characteristic phenotype)
- Families provide informed consent and child provides assent
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01808508
Start Date
September 1 2010
End Date
September 1 2014
Last Update
February 8 2016
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104