N/A
N=23
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Down Syndrome · Obstructive Sleep Apnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01808508 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Epworth Sleepiness Scale From Baseline to End of Study — -1; -0.5; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous positive airway pressure (Device); Sham or placebo continuous positive airway pressure (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Epworth Sleepiness Scale From Baseline to End of Study |
-1; -0.5; 1 | — |
| SECONDARY Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months |
-2; 2; 2 | — |
| SECONDARY Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months |
-0.06; -1.18; 0.36 | — |
| SECONDARY Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 8-20 years
- Down syndrome (based on the characteristic phenotype)
- Families provide informed consent and child provides assent
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01808508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.