Clinical trial NCT01317329: "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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Hypoxia
Hypercapnia
Sleep Disorders
Obesity
Hypertension
Coronary Artery Vasospasm
Right Ventricular Overload
Left Ventricular Function Systolic Dysfunction
Ventricular Hypertrophy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
timeFrame: 14 weeks
Secondary outcomes:
measure: Changes in arterial stiffness between baseline and after CPAP treatment
timeFrame: 14 weeks
measure: Changes in coronary artery flow under a cold pressor test
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wisconsin Sleep
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Claudia E Korcarz, DVM
role: PRINCIPAL_INVESTIGATOR
References:
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.