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

NCT ID: NCT01808508

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Down Syndrome; Obstructive Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1- Continuous positive airway pressure (CPAP)

Group 1 will receive therapeutic CPAP for 4 months.

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure

Intervention Type: DEVICE

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.

Group 2-Sham Continuous positive airway pressure (CPAP)

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

Group Type: PLACEBO_COMPARATOR

Sham or placebo continuous positive airway pressure

Intervention Type: DEVICE

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.

Group 3- 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous positive airway pressure

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.

Intervention Type: DEVICE

Sham or placebo continuous positive airway pressure

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.

Intervention Type: DEVICE

Other Intervention Names

CPAP; Sham or placebo CPAP

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole Marcus, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

11-007964

Identifier Type: -

Identifier Source: org_study_id