Trials / Terminated
TerminatedNCT01403194
Continuous Positive Airway Pressure and Cardiometabolic Risk
Impact of Treatment of Sleep Disordered Breathing With Continuous Positive Airway Pressure (CPAP) on Cardiometabolic Risk Markers
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CPAP/BiPAP | Subjects will be treated with either CPAP or Bi-PAP for three months. |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-07-27
- Last updated
- 2014-05-13
- Results posted
- 2014-05-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01403194. Inclusion in this directory is not an endorsement.