Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)
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Purpose
The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.
| Condition |
|---|
|
Obstructive Sleep Apnea |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea |
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| Estimated Enrollment: | 72 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
OSA
patients diagnosed with obstructive sleep apnea who do not have existing cariovascular disease
|
|
control
patients without obstructive sleep apnea who are matched in weight and age to the OSA patients
|
Detailed Description:
Impaired vascular regulation of the microcirculation is a consequence of Obstructive Sleep Apnea (OSA). Nitric Oxide (NO) related endothelial dysfunction occurs in OSA as the earliest vascular abnormality prior to the manifestation of vascular disease and it results in impaired vasodilatory response to hypoxia. These abnormalities have already been described in OSA patients. The role of oxidative stress in endothelial dysfunction is present in vascular disorders. The presence of oxidative stress in OSA patients is also well established. The effect of increased superoxide on endothelial function has also been described in the literature. The mechanism of this effect is unknown and is the focus of this research.
We hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants: will be 36 patients with newly diagnosed OSA and 36 age and BMI matched controls.
Patients with OSA will be enrolled from the sleep disorders center at OSU among patients who underwent a recent (past 4 weeks) polysomnography that is positive for OSA, and never were treated with CPAP.
Inclusion criteria will be AHI > 15 events per hours.
Inclusion criteria:
1. AHI > 15 events per hours.
Exclusion criteria:
- Hypertension defined by existing treatment with antihypertensives or any measurement of systolic pressure above 130 mmHg, or diastolic pressure above 85 mmHg;
- Dyslipidemia defined by fasting cholesterol above 200; or fasting LDL over 150 mg/dl;
- Diabetes defined as existing diagnosis, hemoglobin A1C >7 or fasting glucose >110 on two separate measurements (standard fasting glucose or HbA1C criteria);
- CAD defined by history of angina, coronary event or abnormal stress test;
- PVD defined by history of stroke, claudication or abnormal Ankle brachial index;
- Concurrent smoking;
- Pregnancy;
- Use of erectile dysfunction drugs, or any medications for chronic conditions; 9)Chronic liver or renal disease. Fasting blood test for glucose, cholesterol, on all participants who have not had these tests in the 6 month prior to enrollment, will be obtained at the time of screening. The remaining criteria will be evaluated by reviewing the medical records and history taking on the day of first visit.
Contacts and Locations| Contact: Brian Patt | brian.patt@osumc.edu |
| United States, Ohio | |
| The Davis Heart and Lung Research Institute | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Brian Patt 614-292-0876 brian.patt@osumc.edu | |
| Principal Investigator: | Rami Khayat, MD | Ohio State University |
More Information
No publications provided
| Responsible Party: | Rami Khayat, Associate Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01027078 History of Changes |
| Other Study ID Numbers: | 2009H0212 |
| Study First Received: | December 4, 2009 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013