"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved" (NCT01317329) | Clinical Trial Compass
CompletedNot Applicable
"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
United States90 participantsStarted 2011-03
Plain-language summary
The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.
Who can participate
Age range21 Years – 50 Years
SexALL
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Inclusion Criteria:
* subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) \>15 events/hour and Epworth score \>10, or an AHI \>20 events/hour
* either sex
* any race
* between 21-50 years old.
Exclusion Criteria:
* Systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg
* Changes in antihypertensive medications in the last 6 weeks
* Restless leg syndrome
* Average overnight oxygen saturation below 80%
* Current use of beta-blockers
* History of coronary artery disease
* History of Stroke
* Atrial fibrillation
* Peripheral vascular disease
* Suspected cardiac valve abnormality
* Ejection fraction \<50%
* Type I and type II Diabetes Mellitus (DM)
* Asthma or confirmed Chronic Obstructive Pulmonary Disease
* Cigarette smoking in the last 6 months
* Raynaud's disease
* Pregnancy (the normal hormonal changes that occur in pregnancy affect greatly arterial stiffness parameters) If a subject becomes pregnant we will discontinue data collection.
* Physically incapable of resting on left lateral decubitus for 40 minutes.
* Mastectomy with lymph node removal that might preclude us to monitor blood pressures on both arms
What they're measuring
1
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy