Sleep Apnea and Vascular Function

Not Applicable

Completed

• Conditions: OSA
• Interventions: Other: Sleep Study

• Registration Number: NCT01717339
• Lead Sponsor: Mayo Clinic

Brief Summary

Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part of these studies we will look at NO signaling pathways in adipose tissue and microvessels from normal and OSA subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Study Start: 2012-11
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Non OSA, and newly diagnosed OSA subjects, naïve to CPAP treatment, aged 18-65 years, with BMI less than or equal to 55 kg/m2, who are free of all chronic diseases including diabetes, and cardiovascular diseases, will be recruited for our study. Subjects with dyslipidemia and hypertension will be allowed to participate in the study. Subjects taking anti-depressents, and anithypertensives will be allowed to participate in the study. Also, subjects taking beta blockers and beta agonists will be allowed to participate in the study.

If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subjects does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

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Exclusion Criteria

• Body weight >450 pounds (204.5kg)
• Pregnancy.
• Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women.
• Postmenopausal
• Smoking
• Use of chronic Medications (aspirin, statins, anti-inflammatory drugs)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Subjects	Sleep Study	Non-OSA (Obstructive sleep apnea) patients
OSA subjects	Sleep Study	(Obstructive sleep apnea) OSA subjects

Primary Outcome Measures

Name	Time	Method
Change in Brachial artery diameter in response to hyperemia.	Baseline and 15 min after hyperemia	Endothelial function test - Arterial endothelial function will be assessed non-invasively by ultrasound examination of the arterial endothelium dependent vasodilation response to reactive hyperemia. The right brachial artery, proximal to the antecubital fossa, will be imaged longitudinally using a linear-array transducer. Flow-mediated endothelium-dependent vasodilation will be assessed by measuring the brachial artery diameter at baseline and during reactive hyperemia. Reactive hyperemia will be induced by deflating a cuff previously inflated to 200 mmHg for 5 minutes in the forearm. Variables will be measured for three consecutive cardiac cycles and the average will be taken.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States