Continuous Positive Airway Pressure and Cardiometabolic Risk

Study Overview
=================
Brief Summary
-----------------
The hypothesis for this study is that children with sleep disordered breathing will benefit from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance. The CPAP machine delivers a predetermined level of pressure. It releases a stream of compressed air through a hose to the nose mask and keeps the upper airway open under continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles during sleep. This machine helps to increase the oxygen flow by keeping the airway open. The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory Positive Airway Pressure (EPAP) during exhalation.

Detailed Description
-----------------
Obese children with Moderate to Severe Sleep Apnea will have baseline evaluation of markers of cardiometabolic risk and insulin resistance. Subjects will then use either the CPAP or BiPAP machine for 3 months and will return for another blood draw for measurement of the markers for cardiometabolic risk and insulin resistance.

Official Title
-----------------
Impact of Treatment of Sleep Disordered Breathing With Continuous Positive Airway Pressure (CPAP) on Cardiometabolic Risk Markers

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Device: CPAP/BiPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index greater than 95th percentile for age and gender Moderate to severe obstructive sleep apnea (OSA) (as defined by an apnea-hypopnea index (AHI) score of ≥5 events per hour). Only patients who provide informed assent or consent and also have consent from a parent will be included. Exclusion Criteria: Predominant central sleep apnea Type 1 Diabetes Type 2 Diabetes Requires use of supplemental oxygen Active infection, cancer, or chronic inflammatory disorder Use of systemic steroids Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP/Bi-PAP<br>Subjects will be treated with either CPAP or Bi-PAP for three months. | Device: CPAP/BiPAP<br>* Subjects will be treated with either CPAP or Bi-PAP for three months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of Fasting Glucose |  | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of Fasting Insulin |  | baseline, 3 months | 
| Change in Level of Lipids |  | baseline, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Disordered Breathing, CPAP, BiPAP, Cardiovascular risk markers