Back to results

Sleep Apnea and Vascular Function

Primary Purpose

OSA

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep Study

About this trial

This is an interventional basic science trial for OSA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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)

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Normal Subjects

OSA subjects

Arm Description

Non-OSA (Obstructive sleep apnea) patients

(Obstructive sleep apnea) OSA subjects

Outcomes

Primary Outcome Measures

Change in Brachial artery diameter in response to 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01717339

First Posted

October 25, 2012

Last Updated

November 8, 2017

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01717339

Brief Title

Sleep Apnea and Vascular Function

Official Title

Sleep Apnea and Vascular Function

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

OSA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Subjects

Arm Type

Other

Arm Description

Non-OSA (Obstructive sleep apnea) patients

Arm Title

OSA subjects

Arm Type

Other

Arm Description

(Obstructive sleep apnea) OSA subjects

Intervention Type

Other

Intervention Name(s)

Sleep Study

Primary Outcome Measure Information:

Title

Change in Brachial artery diameter in response to hyperemia.

Description

Time Frame

Baseline and 15 min after hyperemia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virend K Somers, MD PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sleep Apnea and Vascular Function

We'll reach out to this number within 24 hrs