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

Not Applicable

Completed

• Conditions: Chronic Heart Failure; Sleep Apnea
• Interventions: Device: Nocturnal oxygen; Device: Adaptive servo ventilation

• Registration Number: NCT01187823
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2010-12
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocturnal oxygen therapy	Nocturnal oxygen	-
Adaptive servo ventilation	Adaptive servo ventilation	Bipap® auto SV Advanced

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction confirmed by echocardiography	three months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan