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Clinical Trials/NCT01317329
NCT01317329
Completed
Not Applicable

"Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"

University of Wisconsin, Madison1 site in 1 country90 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
University of Wisconsin, Madison
Enrollment
90
Locations
1
Primary Endpoint
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.

Detailed Description

We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary pressures, endothelial function, etc. We will also assess the reversibility of these changes after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore changes in coronary flow response after 12 weeks of CPAP use compared with baseline.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) \>15 events/hour and Epworth score \>10, or an AHI \>20 events/hour
  • either sex
  • between 21-50 years old.

Exclusion Criteria

  • Systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg
  • Changes in antihypertensive medications in the last 6 weeks
  • Restless leg syndrome
  • Average overnight oxygen saturation below 80%
  • Current use of beta-blockers
  • History of coronary artery disease
  • History of Stroke
  • Atrial fibrillation
  • Peripheral vascular disease
  • Suspected cardiac valve abnormality

Outcomes

Primary Outcomes

Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy

Time Frame: 14 weeks

Ultrasound based brachial artery reactivity tests will be performed at entry before CPAP therapy and at 4, 12 weeks post CPAP use and 5-7 days after CPAP withdrawal

Secondary Outcomes

  • Changes in coronary artery flow under a cold pressor test(13 weeks)
  • Changes in arterial stiffness between baseline and after CPAP treatment(14 weeks)

Study Sites (1)

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