Status:
TERMINATED
Continuous Positive Airway Pressure and Cardiometabolic Risk
Lead Sponsor:
Mayo Clinic
Conditions:
Sleep Disordered Breathing
Eligibility:
All Genders
8-18 years
Phase:
NA
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) ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01403194
Start Date
March 1 2011
End Date
January 1 2013
Last Update
May 13 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905