Clinical trial NCT01808508: Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Official title: Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Obstructive Sleep Apnea Syndrome
Keywords: Down syndrome
Obstructive sleep apnea syndrome
Continuous positive airway pressure
sham or placebo CPAP
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 27
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 8-20 years
2. Down syndrome (based on the characteristic phenotype)
3. Families provide informed consent and child provides assent

Exclusion Criteria:

1. Subjects and families who do not speak English well enough to undergo psychometric testing.
2. Subjects living in institutions where there is no primary caregiver to participate in the neurocognitive/behavioral battery.
3. Major chronic lung disease such as chronic aspiration.
4. Previous or current CPAP therapy.
5. Participation in a weight loss program.
6. Craniofacial or neuromuscular conditions other than those associated with DS.
7. Untreated hypothyroidism. Participants with normal thyroid function tests will be included in the study.

Primary outcomes:
measure: Change in Epworth Sleepiness Scale From Baseline to End of Study
timeFrame: 4 Months
Secondary outcomes:
measure: Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months
timeFrame: 4 Months
measure: Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months
timeFrame: 4 Months
measure: Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months
timeFrame: 4 Months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Carole Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References: