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

"Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Hypertension; Obesity; Hypoxia; Left Ventricular Function Systolic Dysfunction; Sleep Disorders; Hypercapnia; Ventricular Hypertrophy; Right Ventricular Overload; Coronary Artery Vasospasm
• Intervention / Treatment: Other: Clinically prescribed CPAP therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53719-1176
      • Wisconsin Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Clinically prescribed CPAP therapy	Other: Clinically prescribed CPAP therapy; CPAP as prescribed by attending physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks
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.	13 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Claudia E Korcarz, DVM, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (ESTIMATE): March 17, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Coronary Disease; Sleep Apnea, Obstructive; Sleep Wake Disorders; Hypertrophy; Hypoxia; Hypercapnia; Coronary Vasospasm
• Other Study ID Numbers: K23HL094760 (NIH)