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

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Chronic Heart Failure Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nocturnal oxygen therapy

Group Type ACTIVE_COMPARATOR

Nocturnal oxygen

Intervention Type DEVICE

Nocturnal use of oxygen

Adaptive servo ventilation

Bipap® auto SV Advanced

Group Type ACTIVE_COMPARATOR

Adaptive servo ventilation

Intervention Type DEVICE

Nocturnal use of Adaptive servo ventilation

Interventions

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Adaptive servo ventilation

Nocturnal use of Adaptive servo ventilation

Intervention Type DEVICE

Nocturnal oxygen

Nocturnal use of oxygen

Intervention Type DEVICE

Other Intervention Names

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Bipap® auto SV Advanced (Philips Respironics)

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No