Skip to main content
OpenTrials
Completed

NCT Number: NCT01317329

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea, Obstructive Apnea Body Weight Cardiovascular Diseases Coronary Artery Vasospasm Coronary Disease Coronary Vasospasm Dyssomnias Heart Diseases Hypercapnia Hypertension Hypoxia Left Ventricular Function Systolic Dysfunction Mental Disorders Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Right Ventricular Overload Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases Ventricular Hypertrophy

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wisconsin Sleep

Madison, Wisconsin, 53719-1176, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinically prescribed CPAP therapy

Other

CPAP as prescribed by attending physician

Primary outcomes

  1. 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

  1. Changes in arterial stiffness between baseline and after CPAP treatment

    Time frame: 14 weeks

    Subjects will undergo pulse wave velocity testing with applanation tonometry. tonometry recordings will be at entry and after 4 and 12 weeks of CPAP use and 5-7- days after withdrawal.

  2. Changes in coronary artery flow under a cold pressor test

    Time frame: 13 weeks

    A subset of subjects with abnormal endothelial function determined during the baseline scan and good echocardiographic images will be invited to participate on this portion of the test. We will record the response to a cold pressor test (submerging their hand in ice water for 1.5 minutes) on left anterior descending coronary artery velocities with transthoracic echocardiography at baseline and after 12 weeks of CPAP therapy.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2011
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.