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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317329
• Other study ID #: K23HL094760
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Vasospasm
• Coronary Vasospasm
• Hypercapnia
• Hypertension
• Hypertrophy
• Hypoxia
• Left Ventricular Function Systolic Dysfunction
• Obesity
• Right Ventricular Overload
• Sleep Apnea, Obstructive
• Sleep Disorders
• Sleep Wake Disorders
• Ventricular Hypertrophy

Intervention

Other:
• Clinically prescribed CPAP therapy
CPAP as prescribed by attending physician

Locations

Country	Name	City	State
United States	Wisconsin Sleep	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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