Comparison of Continuous Positive Airway Pressure (CPAP) With Autoadjusting CPAP in the Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

This study has been terminated.
(Difficulty with enrollment)
Sponsor:
Collaborators:
ResMed
Great Lakes NeuroTechnologies Inc.
Information provided by (Responsible Party):
Dennis Auckley, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00588848
First received: January 3, 2008
Last updated: July 18, 2013
Last verified: July 2013
Results First Received: October 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: Autoadjusting CPAP (VPAP Auto)
Device: CPAP

  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
Only 11 subjects were recruited and successfully completed the study. This resulted in early termination of the study.

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

Reporting Groups
  Description
AUTOCPAP

An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)

Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).

CPAP

Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)

Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)


Participant Flow:   Overall Study
    AUTOCPAP     CPAP  
STARTED     3     8  
COMPLETED     3     8  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
AUTOCPAP

An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)

Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).

CPAP

Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)

Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)

Total Total of all reporting groups

Baseline Measures
    AUTOCPAP     CPAP     Total  
Number of Participants  
[units: participants]
  3     8     11  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     8     11  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  50.3  ± 9.0     52.5  ± 7.5     51.2  ± 8.2  
Gender  
[units: participants]
     
Female     2     7     9  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     3     8     11  



  Outcome Measures
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1.  Primary:   Sleep Related Hypoxemia   [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]

2.  Secondary:   Apnea-Hypopnea Index (AHI)   [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]

3.  Secondary:   Cardiopulmonary Complications   [ Time Frame: 72 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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

Trial limitations include:

1. Insufficient enrollment to adequately analyze data



  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. Dennis Auckley
Organization: MetroHealth Medical Center
phone: 216-778-7212
e-mail: dauckley@metrohealth.org


Publications:

Responsible Party: Dennis Auckley, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00588848     History of Changes
Other Study ID Numbers: IRB07-00504
Study First Received: January 3, 2008
Results First Received: October 28, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board