Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patients with apnoea-hypopnoea index >15/h
Exclusion Criteria:
- chronic obstructive pulmonary disease
- diabetes mellitus
- coronary artery disease
- congestive heart failure
- chronic renal failure
- known dyslipidemia
- smoking history
- hypothyroidism
- chronic or recent infectious or inflammatory disease
- use of anti-inflammatory or antibiotic drugs, or statins.
- postmenopausal females on estrogen replacement therapy.
Sites / Locations
- Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep apnea
Arm Description
Participants with Obstructive Sleep Apnea (OSA).This arm will undergo a pre-treatment blood draw, six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw 3 and 6 months later. Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)
Outcomes
Primary Outcome Measures
Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365832
Brief Title
Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
Official Title
CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Crete
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.
Detailed Description
OSA is an independent risk factor for a number of cardiovascular diseases. One important possible mechanism underlying cardiovascular disease in patients with OSA is systemic inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP levels are associated with high mortality and morbidity due to cardiovascular disease in men and women. In patients with OSA, the question as to whether or not CRP levels are elevated is still under debate. Although continuous positive airway pressure (CPAP) is effective in the management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels. However, none of the existing studies assessed the influence of gender on the CRP evolution pattern. Therefore, the aim of this study was to investigate possible gender differences in CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6 months after the start of effective CPAP treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep apnea
Arm Type
Experimental
Arm Description
Participants with Obstructive Sleep Apnea (OSA).This arm will undergo a pre-treatment blood draw, six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw 3 and 6 months later.
Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Other Intervention Name(s)
positive pressure ventilation
Intervention Description
Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment blood draw 3 and 6 months after the start of effective CPAP treatment
Primary Outcome Measure Information:
Title
Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.
Time Frame
Day 1, Month 3 and Month 6 post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with apnoea-hypopnoea index >15/h
Exclusion Criteria:
chronic obstructive pulmonary disease
diabetes mellitus
coronary artery disease
congestive heart failure
chronic renal failure
known dyslipidemia
smoking history
hypothyroidism
chronic or recent infectious or inflammatory disease
use of anti-inflammatory or antibiotic drugs, or statins.
postmenopausal females on estrogen replacement therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia E Schiza, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charalampos Mermigkis, MD
Organizational Affiliation
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Izolde Bouloukaki, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
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