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

Primary Purpose

Chronic Heart Failure, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Adaptive servo ventilation
Nocturnal oxygen
Sponsored by
Kyoto University, Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nocturnal oxygen therapy

Adaptive servo ventilation

Arm Description

Bipap® auto SV Advanced

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction confirmed by echocardiography

Secondary Outcome Measures

Sleep quality confirmed by polysomnography
Endothelial function
Sleepiness
Blood pressure
Serum biomarkers
Inflammation, oxidative stress
health-related quality of life
Urinary biomarkers
inflammation, oxidative stress
Heart rate

Full Information

First Posted
August 23, 2010
Last Updated
April 13, 2015
Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Philips Respironics, Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01187823
Brief Title
The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Philips Respironics, Philips Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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,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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Sleep Apnea
Keywords
Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nocturnal oxygen therapy
Arm Type
Active Comparator
Arm Title
Adaptive servo ventilation
Arm Type
Active Comparator
Arm Description
Bipap® auto SV Advanced
Intervention Type
Device
Intervention Name(s)
Adaptive servo ventilation
Other Intervention Name(s)
Bipap® auto SV Advanced (Philips Respironics)
Intervention Description
Nocturnal use of Adaptive servo ventilation
Intervention Type
Device
Intervention Name(s)
Nocturnal oxygen
Intervention Description
Nocturnal use of oxygen
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction confirmed by echocardiography
Time Frame
three months
Secondary Outcome Measure Information:
Title
Sleep quality confirmed by polysomnography
Time Frame
three months
Title
Endothelial function
Time Frame
three months
Title
Sleepiness
Time Frame
three months
Title
Blood pressure
Time Frame
three months
Title
Serum biomarkers
Description
Inflammation, oxidative stress
Time Frame
three months
Title
health-related quality of life
Time Frame
three months
Title
Urinary biomarkers
Description
inflammation, oxidative stress
Time Frame
three months
Title
Heart rate
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuo Chin, MD, PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MIchiaki Mishima, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kimihiko Murase, MD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27099761
Citation
Murase K, Ono K, Yoneda T, Iguchi M, Yokomatsu T, Mizoguchi T, Izumi T, Akao M, Miki S, Nohara R, Ueshima K, Mishima M, Kimura T, White DP, Chin K. Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial. Open Heart. 2016 Mar 31;3(1):e000366. doi: 10.1136/openhrt-2015-000366. eCollection 2016.
Results Reference
derived

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

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