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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187823
• Other study ID #: C-447
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: April 13, 2015
• Start date: December 2010
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Chronic Heart Failure
• Heart Failure
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Adaptive servo ventilation
Nocturnal use of Adaptive servo ventilation
• Nocturnal oxygen
Nocturnal use of oxygen

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (3)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine	Philips Healthcare, Philips Respironics

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction confirmed by echocardiography		three months	No
Secondary	Sleep quality confirmed by polysomnography		three months	No
Secondary	Endothelial function		three months	No
Secondary	Sleepiness		three months	No
Secondary	Blood pressure		three months	No
Secondary	Serum biomarkers	Inflammation, oxidative stress	three months	No
Secondary	health-related quality of life		three months	No
Secondary	Urinary biomarkers	inflammation, oxidative stress	three months	No
Secondary	Heart rate		three months	No