Clinical Trials Directory

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

TypeNameDescription
DEVICECPAP/BiPAPSubjects 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.