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

This study has been completed.
Sponsor:
Collaborators:
Philips Respironics
Philips Healthcare
Information provided by (Responsible Party):
Kimihiko Murase, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01187823
First received: August 23, 2010
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
Chronic Heart Failure
Sleep Apnea
Device: Adaptive servo ventilation
Device: Nocturnal oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Left ventricular ejection fraction confirmed by echocardiography [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep quality confirmed by polysomnography [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Sleepiness [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Serum biomarkers [ Time Frame: three months ] [ Designated as safety issue: No ]
    Inflammation, oxidative stress

  • health-related quality of life [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Urinary biomarkers [ Time Frame: three months ] [ Designated as safety issue: No ]
    inflammation, oxidative stress

  • Heart rate [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: December 2010
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187823

Locations
Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Philips Respironics
Philips Healthcare
Investigators
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

No publications provided

Responsible Party: Kimihiko Murase, medical doctor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01187823     History of Changes
Other Study ID Numbers: C-447
Study First Received: August 23, 2010
Last Updated: July 30, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University, Graduate School of Medicine:
Chronic heart failure
Central sleep apnea
Obstructive sleep apnea
Adaptive servo ventilation

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Cardiovascular Diseases
Dyssomnias
Heart Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 24, 2014