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Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01199042
First received: September 9, 2010
Last updated: March 28, 2016
Last verified: March 2016
Results First Received: August 5, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cheyne-Stokes Respiration
Sleep Apnea, Central
Intervention: Device: BiPAP autoSV Advanced

  Participant Flow
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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
  Description
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  
STARTED     29  
COMPLETED     27  
NOT COMPLETED     2  
Didn't meet inclusion/exclusion criteria                 2  

Period 2:   At Home (3 Months)
    Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV  
STARTED     27  
COMPLETED     26  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Mean (Standard Deviation)
  59  (12)  
Gender  
[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
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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
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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
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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
e-mail: shahrokhjavaheri@icloud.com


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

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01199042     History of Changes
Other Study ID Numbers: ST-1001-ASVWO-MS
Study First Received: September 9, 2010
Results First Received: August 5, 2015
Last Updated: March 28, 2016
Health Authority: United States: Institutional Review Board