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NCT Number: NCT01187823

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

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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Key information

Conditions

Chronic Heart Failure Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive servo ventilation

Device

Nocturnal use of Adaptive servo ventilation

Other names: Bipap® auto SV Advanced (Philips Respironics)

Nocturnal oxygen

Device

Nocturnal use of oxygen

Primary outcomes

  1. Left ventricular ejection fraction confirmed by echocardiography

    Time frame: three months

Secondary outcomes

  1. Sleep quality confirmed by polysomnography

    Time frame: three months

  2. Endothelial function

    Time frame: three months

  3. Sleepiness

    Time frame: three months

  4. Blood pressure

    Time frame: three months

  5. Serum biomarkers

    Time frame: three months

    Inflammation, oxidative stress

  6. health-related quality of life

    Time frame: three months

  7. Urinary biomarkers

    Time frame: three months

    inflammation, oxidative stress

  8. Heart rate

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Collaborators

  • Philips Healthcare
  • Philips Respironics

Registry information

Official study title

Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 24, 2010
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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