The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients

Study Overview
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Brief Summary
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The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.

Detailed Description
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Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective modalities. However,in fact, majority of CHF patients are complicated not only with CSA but with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV function. The present study is prospective randomised study to compare the effects of nocturnal oxygen therapy and Bipap® auto SV Advanced.

Official Title
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Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea

Conditions
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Chronic Heart Failure, Sleep Apnea

Intervention / Treatment
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* Device: Adaptive servo ventilation
* Device: Nocturnal oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left ventricular ejection fraction<50% confirmed by echocardiography Apnea hypopnea index(AHI)>=20 confirmed by overnight polysomnography More than 15% of AHI is due to CSA Exclusion Criteria: Changes of cardioactive drug prescriptions within 6 weeks Admission due to cardiovascular events within 6 weeks Ever used CPAP or ASV for sleep apnea Ever used nocturnal oxgen therapy Subjects with acute exacerbation of chronic heart failure Operation for upper airway within 90 days Renal dialysis History of stroke with neurological deficit

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nocturnal oxygen therapy<br> | Device: Nocturnal oxygen<br>* Nocturnal use of oxygen<br>|
| Active Comparator: Adaptive servo ventilation<br>Bipap® auto SV Advanced | Device: Adaptive servo ventilation<br>* Nocturnal use of Adaptive servo ventilation<br>* Other names: Bipap® auto SV Advanced (Philips Respironics);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction confirmed by echocardiography |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality confirmed by polysomnography |  | three months | 
| Endothelial function |  | three months | 
| Sleepiness |  | three months | 
| Blood pressure |  | three months | 
| Serum biomarkers | Inflammation, oxidative stress | three months | 
| health-related quality of life |  | three months | 
| Urinary biomarkers | inflammation, oxidative stress | three months | 
| Heart rate |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation