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| Name | Class |
|---|---|
| Philips Respironics | INDUSTRY |
| Philips Healthcare | INDUSTRY |
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The aim of this study is to compare the effects of Adaptive Servo Ventilation (BipapĀ® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.
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 BipapĀ® 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 BipapĀ® auto SV Advanced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nocturnal oxygen therapy | Active Comparator |
| |
| Adaptive servo ventilation | Active Comparator | BipapĀ® auto SV Advanced |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive servo ventilation | Device | Nocturnal use of Adaptive servo ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction confirmed by echocardiography | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality confirmed by polysomnography | three months | |
| Endothelial function | three months | |
| Sleepiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuo Chin, MD, PhD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| Takeshi Kimura, MD,PhD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| MIchiaki Mishima, MD,PhD | Kyoto University, Graduate School of Medicine | Study Chair |
| Kimihiko Murase, MD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27099761 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020182 | Sleep Apnea, Central |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Nocturnal oxygen | Device | Nocturnal use of oxygen |
|
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |