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Clinical Trials/NCT01854398
NCT01854398
Completed
Not Applicable

The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea

Yonsei University1 site in 1 country60 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Yonsei University
Enrollment
60
Locations
1
Primary Endpoint
The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3 months of CPAP therapy in OSA patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. Patients with severe OSA (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP therapy and parameters will be compared.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patietns≥20 and ≤75 years-old
  • Patients who diagnosed as obstructive sleep apnea and AHI\>30 on polysomnography

Exclusion Criteria

  • Age \< 20 years-old
  • Left ventricular dysfunction (LVEF\<50%) or structural heart disease on transthoracic echocardiography
  • Diabetes mellitus
  • Significant cardiac valvular disease (≥moderate)
  • Severe hypertension (\>180/110mmHg)
  • Moderate or severe kidney disease (eGFR \< 60 mL/min )
  • Clinically significant liver disease
  • History of coronary artery disease
  • malignancy or autoimmune disease
  • Acute/chronic infection status

Outcomes

Primary Outcomes

The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.

Time Frame: after 3 months intervention (CPAP)

The differences of supine bicycle exercise echocardiogrphic parameters (diastolic function grade, mitral inflow parameters, mitral tissue doppler parameters, E/E') and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.

Study Sites (1)

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