"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
This study is enrolling participants by invitation only.
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Claudia E Korcarz, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01317329
First received: March 14, 2011
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Apnea, Obstructive Hypoxia Hypercapnia Sleep Disorders Obesity Hypertension Coronary Artery Vasospasm Right Ventricular Overload Left Ventricular Function Systolic Dysfunction Ventricular Hypertrophy |
Other: Clinically prescribed CPAP therapy |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | "Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved" |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 130 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Clinically prescribed CPAP therapy
Clinically prescribed CPAP therapy
|
Other: Clinically prescribed CPAP therapy
CPAP as prescribed by attending physician
|
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| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317329
Locations
| United States, Wisconsin | |
| Wisconsin Sleep | |
| Madison, Wisconsin, United States, 53719-1176 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Claudia E Korcarz, DVM | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | Claudia E Korcarz, Senior Scientist, University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01317329 History of Changes |
| Other Study ID Numbers: | K23HL094760 |
| Study First Received: | March 14, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Vasospasm Hypercapnia Hypertension Hypertrophy Obesity Sleep Apnea Syndromes Sleep Disorders Parasomnias Anoxia Sleep Apnea, Obstructive Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Pathological Conditions, Anatomical Overnutrition Nutrition Disorders Overweight Body Weight Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Nervous System Diseases Neurologic Manifestations Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013