Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome (TRIO)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Down Syndrome; Obstructive Sleep Apnea Syndrome

Treatments: Device: Continuous positive airway pressure; Device: Sham or placebo continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT01808508

11-007964

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 8 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

27 participants in 3 patient groups, including a placebo group

Group 1- Continuous positive airway pressure (CPAP)

Active Comparator group

Description:

Group 1 will receive therapeutic CPAP for 4 months.

Treatment:

Device: Continuous positive airway pressure

Group 2-Sham Continuous positive airway pressure (CPAP)

Placebo Comparator group

Description:

Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.

Treatment:

Device: Sham or placebo continuous positive airway pressure

Group 3- No Intervention

No Intervention group

Description:

Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.