Bipap Automatic Servo Ventilation (autoSV) Advanced in Central 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. Identifier: NCT01199042
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Information provided by (Responsible Party):
Philips Respironics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cheyne-Stokes Respiration
Sleep Apnea, Central
Intervention: Device: BiPAP autoSV Advanced

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-nine patients were enrolled between September 2010 and February 2013. Two participants did not meet) criteria after centralized scoring of diagnostic and CPAP polysomnograms (PSGs) and were excluded from analysis. Twenty-seven participants (five women) completed 3 nights in-laboratory attended PSG, and 26 completed 3 months of follow-up.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.

Participant Flow for 2 periods

Period 1:   Sleep Laboratory (3 Nights)
    Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV
Didn't meet inclusion/exclusion criteria                2 

Period 2:   At Home (3 Months)
    Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV
Lost to Follow-up                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Diagnostic, Then CPAP, Then BiPAP autoSV Advanced Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)

Baseline Measures
   Diagnostic, Then CPAP, Then BiPAP autoSV Advanced 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 59  (12) 
[Units: Participants]
Female   5 
Male   22 
Race/Ethnicity, Customized 
[Units: Participants]
African American   1 
Caucasian   25 
African American, Irish, Native American   1 
Region of Enrollment 
[Units: Participants]
United States   27 

  Outcome Measures

1.  Primary:   Apnea/Hypopnea Index (AHI)   [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ]

2.  Secondary:   Epworth Sleepiness Scale   [ Time Frame: 3 months ]

3.  Secondary:   Breathing Event Indexes   [ Time Frame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment ]

4.  Secondary:   Average Therapy Pressure Values   [ Time Frame: 3 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Shahrokh Javaheri
Organization: Bethesda North Hospital
phone: 513-793-7378

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Philips Respironics Identifier: NCT01199042     History of Changes
Other Study ID Numbers: ST-1001-ASVWO-MS
First Submitted: September 9, 2010
First Posted: September 10, 2010
Results First Submitted: August 5, 2015
Results First Posted: April 28, 2016
Last Update Posted: April 28, 2016