Clinical Trial 7194

Baltimore, MD 21224

Study Summary:

This study is being conducted to help doctors understand how to best treat a condition known as obstructive sleep apnea in patients with heart disease or those at risk for heart disease who also snore and who may stop breathing at night. These symptoms are suggestive of a condition known as obstructive sleep apnea (OSA). However, often this condition is not diagnosed or treated, and may contribute to the development of high blood pressure, heart disease, diabetes, and stroke. The purpose of this study is to determine whether treating patients with heart disease who also have symptoms of obstructive sleep apnea such as loud snoring, breathing pauses, and gasping or snorting during sleep improves their heart disease risk factors. The study also will determine whether treatment of the snoring and breathing problems with additional oxygen worn at night through a small plastic tube worn near the nose is as effective as the standard therapy for sleep apnea, which is a device which blows air (not oxygen) into the throat, keeping the throat open and preventing snoring.

Qualified Participants Must:

• Be 45-75 years of age
• Have a history of heart disease or have several risk factors for heart disease

Qualified Participants May Receive:

(a) An electrocardiogram; (b) Blood and urine sampling to measure the levels of glucose, insulin, cholesterol, fats and other factor; (c) Blood pressure measurements; (d) Blood vessel function using a finger probe to measure how the size of your blood vessels changes in response to pressure; (e) Height, weight and other body measurements; (f) Interviews about your health, sleep and other related information; (g) Monitoring of your breathing and heart rhythm during sleep with a portable machine that counts the number of dips in blood oxygen; and (h) Treatment in some subjects with PAP (positive airway pressure – a machine that keeps the upper airway open during sleep) or oxygen (delivered by a cannula under the nose).

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.