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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854398
• Other study ID #: 1-2013-0021
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: January 24, 2017
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after 3 months intervention (CPAP)