Continuous Positive Airway Pressure and Cardiometabolic Risk
Stopped early · Not applicable
Conditions studied: Sleep Disordered Breathing
In brief
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.
Key facts
- Study ID
- NCT01403194
- Run by
- Mayo Clinic
- People needed
- 11
- Starts
- 2011-03-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-05-13
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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