Study to Assess the Changes in Blood Clotting Factors and Blood Vessel Wall Function in Obstructive Sleep Apnea

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

Obstructive sleep apnea is a condition in which people have decreased breathing during their sleep. Untreated sleep apnea has been linked to increased risk for cardiovascular diseases. This research study is looking at blood clotting factors and blood vessel function in health volunteers and patients with newly diagnosed or untreated obstructive sleep apnea to better understand the underlying mechanisms for increased cardiovascular risk.

Key facts

Study ID

NCT00936481

Run by

Vanderbilt University

People needed

34

Starts

2008-02-01

Expected to finish

2012-04-01

Last updated by the study team

2013-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 years or older.
• Subjects are able and willing to provide informed consent.
• Subjects are willing to cooperate with polysomnography and have serial blood draws over a 24-hour period.
• Evidence for OSA (AHI>5 events/hour) without treatment or suspected OSA based on symptoms in the patient group.
• Body mass index of 25-45

You may not qualify if…

• History of myocardial infarction, stroke or transient ischemic attack (TIA) or peripheral vascular disease.
• History of chronic diseases such as diabetes mellitus, uncontrolled hypertension (SBP >160, DBP > 120), renal failure on dialysis, cancer, autoimmune or liver disease.
• A significant history of medical or psychiatric disease that may impair participation in the trial.
• Evidence of medical instability (cardiac arrhythmias, congestive heart failure, pulmonary disease) that require an expedited evaluation and treatment of the OSA.
• History of alcohol, or drug abuse during the one-year-period prior to trial participation.
• Current use of tobacco products.
• Current treatment with angiotensin converting enzyme-inhibitors and or chronic use of non-steroidal anti-inflammatory agents.
• Another primary sleep disorder that requires intervention with medications or cause disrupted sleep.
• Patients with unusual sleep or wake habits, including shift work.
• Transmeridian travel in the previous 3 months.
• Patients with OSA who have already received treatment with CPAP, surgery or oral appliance.
• Pregnancy; as hormonal changes affect sleep disordered breathing.

Where it is running

• Vanderbilt University Medical Center,Department of Neurology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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