Continuous Positive Airway Pressure and Cardiometabolic Risk

Not Applicable

Terminated

• Conditions: Sleep Disordered Breathing
• Interventions: Device: CPAP/BiPAP

• Registration Number: NCT01403194
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-27
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-04
• Results First Submitted: 2014-04-14
• Results First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Results First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. Body mass index greater than 95th percentile for age and gender
2. 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.

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Exclusion Criteria

1. Predominant central sleep apnea
2. Type 1 Diabetes
3. Type 2 Diabetes
4. Requires use of supplemental oxygen
5. Active infection, cancer, or chronic inflammatory disorder
6. Use of systemic steroids
7. Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP/Bi-PAP	CPAP/BiPAP	Subjects will be treated with either CPAP or Bi-PAP for three months.

Primary Outcome Measures

Name	Time	Method
Change in Level of Fasting Glucose	baseline, 3 months

Secondary Outcome Measures

Name	Time	Method
Change in Level of Fasting Insulin	baseline, 3 months
Change in Level of Lipids	baseline, 3 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States