Status:

COMPLETED

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

Lead Sponsor:

Kyoto University, Graduate School of Medicine

Collaborating Sponsors:

Philips Respironics

Philips Healthcare

Conditions:

Chronic Heart Failure

Sleep Apnea

Eligibility:

All Genders

20-80 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2014

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT01187823

Start Date

December 1 2010

End Date

March 1 2014

Last Update

April 14 2015

Active Locations (1)

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Kyoto University Hospital

Kyoto, Kyoto, Japan, 606-8507