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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Claudia E Korcarz, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01317329
First received: March 14, 2011
Last updated: January 15, 2013
Last verified: January 2013
  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: Open Label
Primary Purpose: Treatment
Official Title: "Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 130
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Claudia E Korcarz, Senior Scientist, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01317329     History of Changes
Other Study ID Numbers: K23HL094760
Study First Received: March 14, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014