"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 6, 2020
September 1, 2015
3.5 years
March 14, 2011
March 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in arterial stiffness between baseline and after CPAP treatment
14 weeks
Changes in coronary artery flow under a cold pressor test
13 weeks
Study Arms (1)
Clinically prescribed CPAP therapy
OTHERClinically prescribed CPAP therapy
Interventions
CPAP as prescribed by attending physician
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wisconsin Sleep
Madison, Wisconsin, 53719-1176, United States
Related Publications (1)
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.
PMID: 27039928DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia E Korcarz, DVM
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 17, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
March 6, 2020
Record last verified: 2015-09