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

This study has been completed.
Sponsor:
Information provided by:
University of Crete
ClinicalTrials.gov Identifier:
NCT01365832
First received: May 17, 2011
Last updated: June 3, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
 Procedure: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Crete:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: positive pressure ventilation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365832

Locations
Greece
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
  More Information

No publications provided

Responsible Party: Sophia Schiza, University of Crete
ClinicalTrials.gov Identifier: NCT01365832     History of Changes
Other Study ID Numbers: OSACRP-02
Study First Received: May 17, 2011
Last Updated: June 3, 2011
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013