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

April 13, 2015 updated by: Kimihiko Murase, Kyoto University, Graduate School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Bipap® auto SV Advanced (Philips Respironics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction confirmed by echocardiography
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: three months
three months
Sleep quality confirmed by polysomnography
Time Frame: three months
three months
Endothelial function
Time Frame: three months
three months
Sleepiness
Time Frame: three months
three months
Serum biomarkers
Time Frame: three months
Inflammation, oxidative stress
three months
health-related quality of life
Time Frame: three months
three months
Urinary biomarkers
Time Frame: three months
inflammation, oxidative stress
three months
Heart rate
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Collaborators

Philips Healthcare
Philips Respironics

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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