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Sleep Apnea Treatment After Stroke (SATS)

This study has been terminated.
(Poor recruitment. Funding expired.)
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT00282815
First received: January 26, 2006
Last updated: January 31, 2013
Last verified: December 2012
History of Changes
Results First Received: June 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Obstructive Sleep Apnea
Stroke
Interventions: Device: continuous positive airway pressure or CPAP
Device: sham 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
Patients enrolled from inpatient neurology service.

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
Active Continuous Positive Airway Pressure (CPAP) No text entered.
Sham Continuous Positive Airway Pressure (CPAP) Subtherapeutic CPAP

Participant Flow:   Overall Study
    Active Continuous Positive Airway Pressure (CPAP)     Sham Continuous Positive Airway Pressure (CPAP)  
STARTED     15     17  
COMPLETED     8     11  
NOT COMPLETED     7     6  



  Baseline Characteristics
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Reporting Groups
  Description
Active Continuous Positive Airway Pressure (CPAP) No text entered.
Sham Continuous Positive Airway Pressure (CPAP) Subtherapeutic CPAP
Total Total of all reporting groups

Baseline Measures
    Active Continuous Positive Airway Pressure (CPAP)     Sham Continuous Positive Airway Pressure (CPAP)     Total  
Number of Participants  
[units: participants]
 		  15     17     32  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     8     5     13  
>=65 years     7     12     19  
Age  
[units: years]
Mean ± Standard Deviation 		  61  ± 16     74  ± 16     65  ± 16  
Gender  
[units: participants]
 		     
Female     10     4     14  
Male     5     13     18  
Region of Enrollment  
[units: participants]
 		     
United States     15     17     32  



  Outcome Measures
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1.  Primary:   Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Primary:   Number of Subjects Who Withdraw From Study.   [ Time Frame: 3 months ]
  Show Outcome Measure 2

3.  Secondary:   Barthel Index   [ Time Frame: 3 months ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Attrition pre-randomization and while in randomized treatment led to small numbers.  


Results Point of Contact:  
Name/Title: Devin Brown, MD
Organization: University of Michigan
phone: 734-936-9075
e-mail: devinb@umich.edu


Publications of Results:


Responsible Party: Devin Brown, University of Michigan
ClinicalTrials.gov Identifier: NCT00282815     History of Changes
Other Study ID Numbers: K23NS51202
Study First Received: January 26, 2006
Results First Received: June 21, 2011
Last Updated: January 31, 2013
Health Authority: United States: Federal Government