Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Continuous positive airway pressure, diastolic function
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.
Interventions
DEVICECPAP group
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.
DEVICEsham-CPAP group
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed