"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive Hypoxia Hypercapnia Sleep Disorders Obesity Hypertension Coronary Artery Vasospasm Right Ventricular Overload Left Ventricular Function Systolic Dysfunction Ventricular Hypertrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clinically prescribed CPAP therapy

Group Type OTHER

Clinically prescribed CPAP therapy

Intervention Type OTHER

CPAP as prescribed by attending physician

Interventions

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Clinically prescribed CPAP therapy

CPAP as prescribed by attending physician

Intervention Type OTHER

Eligibility Criteria

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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
* any race
* 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
* Ejection fraction \<50%
* Type I and type II Diabetes Mellitus (DM)
* Asthma or confirmed Chronic Obstructive Pulmonary Disease
* Cigarette smoking in the last 6 months
* Raynaud's disease
* Pregnancy (the normal hormonal changes that occur in pregnancy affect greatly arterial stiffness parameters) If a subject becomes pregnant we will discontinue data collection.
* Physically incapable of resting on left lateral decubitus for 40 minutes.
* Mastectomy with lymph node removal that might preclude us to monitor blood pressures on both arms

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No