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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01187823
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : April 14, 2015
Sponsor:
Collaborators:
Philips Respironics
Philips Healthcare
Information provided by (Responsible Party):
Kimihiko Murase, Kyoto University, Graduate School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Sleep Apnea Device: Adaptive servo ventilation Device: Nocturnal oxygen Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nocturnal oxygen therapy Device: Nocturnal oxygen
Nocturnal use of oxygen
Active Comparator: Adaptive servo ventilation
Bipap® auto SV Advanced
 Device: Adaptive servo ventilation
Nocturnal use of Adaptive servo ventilation
Other Name: Bipap® auto SV Advanced (Philips Respironics)


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular ejection fraction confirmed by echocardiography [ Time Frame: three months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187823


Locations
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Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Philips Respironics
Philips Healthcare
Investigators
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Principal Investigator: Kazuo Chin, MD, PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Takeshi Kimura, MD,PhD Kyoto University, Graduate School of Medicine
Study Chair: MIchiaki Mishima, MD,PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Kimihiko Murase, MD Kyoto University, Graduate School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kimihiko Murase, medical doctor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01187823    
Other Study ID Numbers: C-447
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: July 2014
Keywords provided by Kimihiko Murase, Kyoto University, Graduate School of Medicine:
Chronic heart failure
Central sleep apnea
Obstructive sleep apnea
Adaptive servo ventilation
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases