- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854398
The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
January 24, 2017 updated by: Yonsei University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CPAP group
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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.
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Sham Comparator: sham-CPAP group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
Time Frame: after 3 months intervention (CPAP)
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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.
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after 3 months intervention (CPAP)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 10, 2013
First Submitted That Met QC Criteria
May 14, 2013
First Posted (Estimate)
May 15, 2013
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2013-0021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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