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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CPAP group

Group Type EXPERIMENTAL

CPAP group

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

sham-CPAP group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No