This trial is active, not recruiting.

Conditions down syndrome, obstructive sleep apnea syndrome
Treatments continuous positive airway pressure, sham or placebo continuous positive airway pressure
Sponsor Children's Hospital of Philadelphia
Start date September 2010
End date March 2014
Trial size 27 participants
Trial identifier NCT01808508, 11-007964


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Group 1 will receive therapeutic CPAP for 4 months.
continuous positive airway pressure CPAP
Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open.
(Placebo Comparator)
Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.
sham or placebo continuous positive airway pressure Sham or placebo CPAP
Sham or placebo CPAP is a machine used instead of therapeutic CPAP. This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS.
(No Intervention)
Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.

Primary Outcomes

time frame: at baseline

Secondary Outcomes

Behavioral domain
time frame: at baseline
The distance walked on a 6 minute walk test
time frame: at baseline
Left ventricular mass index
time frame: at baseline

Eligibility Criteria

Male or female participants from 8 years up to 20 years old.

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.

Additional Information

Official title Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Principal investigator Carole Marcus, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.