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

Yonsei University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

sham-CPAP groupDEVICE

Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months. Sham CPAP consists of a CPAP machine that is modified to include a large hidden leak in the exhaust port of the mask to disperse the therapeutic pressure.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 * Pregnant status * Patients taking anxiolytics or sedatives

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.

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.

Time frame: after 3 months intervention (CPAP)