"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
- Conditions
- HypertensionHypercapniaVentricular HypertrophySleep Apnea, ObstructiveSleep DisordersObesityLeft Ventricular Function Systolic DysfunctionHypoxiaCoronary Artery VasospasmRight Ventricular Overload
- Interventions
- Other: Clinically prescribed CPAP therapy
- Registration Number
- NCT01317329
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clinically prescribed CPAP therapy Clinically prescribed CPAP therapy Clinically prescribed CPAP therapy
- Primary Outcome Measures
Name Time Method Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy 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
Name Time Method Changes in coronary artery flow under a cold pressor test 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.
Changes in arterial stiffness between baseline and after CPAP treatment 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.
Trial Locations
- Locations (1)
Wisconsin Sleep
🇺🇸Madison, Wisconsin, United States