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Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)

Sponsor
University of Crete (Other)
Overall Status
Completed
CT.gov ID
NCT01365832
Collaborator
(none)
436
Enrollment
1
Location
1
Arm
29
Duration (Months)
15
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Continuous Positive Airway Pressure (CPAP)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
436 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep apnea

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)

Procedure: Continuous Positive Airway Pressure (CPAP)
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
Other Names:
  • positive pressure ventilation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment. [Day 1, Month 3 and Month 6 post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete Heraklion Crete Greece 71110

    Sponsors and Collaborators

    • University of Crete

    Investigators

    • Study Chair: Sophia E Schiza, MD, PhD, University of Crete
    • Study Director: Charalampos Mermigkis, MD, Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
    • Principal Investigator: Izolde Bouloukaki, MD, PhD, University of Crete

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01365832
    Other Study ID Numbers:
    • OSACRP-02
    First Posted:
    Jun 3, 2011
    Last Update Posted:
    Jun 6, 2011
    Last Verified:
    Apr 1, 2011
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of Jun 6, 2011