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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317329
First Posted: March 17, 2011
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Sleep Apnea, Obstructive Hypoxia Hypercapnia Sleep Disorders Obesity Hypertension Coronary Artery Vasospasm Right Ventricular Overload Left Ventricular Function Systolic Dysfunction Ventricular Hypertrophy Other: Clinically prescribed CPAP therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 90
Study Start Date: March 2011
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Clinically prescribed CPAP therapy
Clinically prescribed CPAP therapy
Other: Clinically prescribed CPAP therapy
CPAP as prescribed by attending physician

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317329


Locations
United States, Wisconsin
Wisconsin Sleep
Madison, Wisconsin, United States, 53719-1176
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Claudia E Korcarz, DVM University of Wisconsin, Madison
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01317329     History of Changes
Other Study ID Numbers: K23HL094760 ( U.S. NIH Grant/Contract )
First Submitted: March 14, 2011
First Posted: March 17, 2011
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hypoxia
Sleep Wake Disorders
Parasomnias
Hypertrophy
Sleep Apnea, Obstructive
Hypercapnia
Coronary Vasospasm
Signs and Symptoms, Respiratory
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Pathological Conditions, Anatomical
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases