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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP group; Device: sham-CPAP group

• Registration Number: NCT01854398
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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
• Pregnant status
• Patients taking anxiolytics or sedatives

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP group	CPAP group	-
sham-CPAP group	sham-CPAP group	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of