The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CPAP group
sham-CPAP group
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Continuous positive airway pressure, diastolic function
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
- Pregnant status
- Patients taking anxiolytics or sedatives
Sites / Locations
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CPAP group
sham-CPAP group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01854398
Brief Title
The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Continuous positive airway pressure, diastolic function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP group
Arm Type
Experimental
Arm Title
sham-CPAP group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
CPAP group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham-CPAP group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Pregnant status
Patients taking anxiolytics or sedatives
Facility Information:
Facility Name
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29386335
Citation
Shim CY, Kim D, Park S, Lee CJ, Cho HJ, Ha JW, Cho YJ, Hong GR. Effects of continuous positive airway pressure therapy on left ventricular diastolic function: a randomised, sham-controlled clinical trial. Eur Respir J. 2018 Jan 31;51(2):1701774. doi: 10.1183/13993003.01774-2017. Print 2018 Feb.
Results Reference
derived
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The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
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