Status:
COMPLETED
Study to Assess the Changes in Blood Clotting Factors and Blood Vessel Wall Function in Obstructive Sleep Apnea
Lead Sponsor:
Vanderbilt University
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Cardiovascular disease (CVD), which includes strokes, has been the number one killer in the United States.Each year about 700,000 people experience a new or recurrent stroke, which translates into abo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00936481
Start Date
February 1 2008
End Date
April 1 2012
Last Update
October 25 2013
Active Locations (1)
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1
Vanderbilt University Medical Center,Department of Neurology
Nashville, Tennessee, United States, 37232