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

NCT01365832 | Completed

• 1 other identifier: OSACRP-02
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Sleep apnea

EXPERIMENTAL

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)

Interventions

Continuous Positive Airway Pressure (CPAP) PROCEDURE

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

Also known as: positive pressure ventilation

Sleep apnea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with apnoea-hypopnoea index \>15/h

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete

Heraklion, Crete, 71110, Greece

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Sophia E Schiza, MD, PhD

  University of Crete

  STUDY CHAIR

• Charalampos Mermigkis, MD

  Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece

  STUDY DIRECTOR

• Izolde Bouloukaki, MD, PhD

  University of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: June 3, 2011
• Study Start: January 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 6, 2011

Record last verified: 2011-04

Locations

GR (1)