"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"

Completed · Not applicable

Conditions studied: Sleep Apnea, Obstructive, Hypoxia, Hypercapnia, Sleep Disorders, Obesity, Hypertension, Coronary Artery Vasospasm, Right Ventricular Overload, Left Ventricular Function Systolic Dysfunction, Ventricular Hypertrophy

In brief

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.

Key facts

Study ID

NCT01317329

Run by

University of Wisconsin, Madison

People needed

90

Starts

2011-03-01

Expected to finish

2014-12-01

Last updated by the study team

2020-03-06

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Wisconsin Sleep — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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