Clinical trial NCT01187823: The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients
Official title: Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Sleep Apnea
Keywords: Chronic heart failure
Central sleep apnea
Obstructive sleep apnea
Adaptive servo ventilation
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Philips Respironics
name: Philips Healthcare
First posted: 2010-08-24
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction confirmed by echocardiography
timeFrame: three months
Secondary outcomes:
measure: Sleep quality confirmed by polysomnography
timeFrame: three months
measure: Endothelial function
timeFrame: three months
measure: Sleepiness
timeFrame: three months
measure: Blood pressure
timeFrame: three months
measure: Serum biomarkers
timeFrame: three months
measure: health-related quality of life
timeFrame: three months
measure: Urinary biomarkers
timeFrame: three months
measure: Heart rate
timeFrame: three months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Kazuo Chin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: Takeshi Kimura, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: MIchiaki Mishima, MD,PhD
role: STUDY_CHAIR
affiliation: Kyoto University, Graduate School of Medicine
name: Kimihiko Murase, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murase K, Ono K, Yoneda T, Iguchi M, Yokomatsu T, Mizoguchi T, Izumi T, Akao M, Miki S, Nohara R, Ueshima K, Mishima M, Kimura T, White DP, Chin K. Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial. Open Heart. 2016 Mar 31;3(1):e000366. doi: 10.1136/openhrt-2015-000366. eCollection 2016.