Back to results"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
Primary Purpose
Sleep Apnea, Obstructive, Hypoxia, Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinically prescribed CPAP therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
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
- 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
Sites / Locations
- Wisconsin Sleep
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinically prescribed CPAP therapy
Arm Description
Clinically prescribed CPAP therapy
Outcomes
Primary Outcome Measures
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
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
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
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.
Full Information
NCT ID
NCT01317329
First Posted
March 14, 2011
Last Updated
March 4, 2020
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01317329
Brief Title
"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
Official Title
"Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Hypoxia, Hypercapnia, Sleep Disorders, Obesity, Hypertension, Coronary Artery Vasospasm, Right Ventricular Overload, Left Ventricular Function Systolic Dysfunction, Ventricular Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinically prescribed CPAP therapy
Arm Type
Other
Arm Description
Clinically prescribed CPAP therapy
Intervention Type
Other
Intervention Name(s)
Clinically prescribed CPAP therapy
Intervention Description
CPAP as prescribed by attending physician
Primary Outcome Measure Information:
Title
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
Description
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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Changes in arterial stiffness between baseline and after CPAP treatment
Description
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.
Time Frame
14 weeks
Title
Changes in coronary artery flow under a cold pressor test
Description
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.
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia E Korcarz, DVM
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wisconsin Sleep
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719-1176
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27039928
Citation
Korcarz CE, Benca R, Barnet JH, Stein JH. Treatment of Obstructive Sleep Apnea in Young and Middle-Aged Adults: Effects of Positive Airway Pressure and Compliance on Arterial Stiffness, Endothelial Function, and Cardiac Hemodynamics. J Am Heart Assoc. 2016 Apr 3;5(4):e002930. doi: 10.1161/JAHA.115.002930.
Results Reference
derived
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