Chronic Heart Failure, Sleep Apnea
Conditions
Keywords
Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation
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.
Interventions
Nocturnal use of Adaptive servo ventilation
DEVICENocturnal oxygen
Nocturnal use of oxygen
Sponsors
Philips Respironics
Philips Healthcare
Kyoto University, Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction confirmed by echocardiography | three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | three months | — |
| Sleepiness | three months | — |
| Blood pressure | three months | — |
| Sleep quality confirmed by polysomnography | three months | — |
| health-related quality of life | three months | — |
| Urinary biomarkers | three months | inflammation, oxidative stress |
| Heart rate | three months | — |
| Serum biomarkers | three months | Inflammation, oxidative stress |
Countries
Japan
Outcome results
None listed