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Sleep Apnea Treatment After Stroke (SATS)

This study has been terminated.
(Poor recruitment. Funding expired.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282815
First Posted: January 27, 2006
Last Update Posted: March 11, 2013
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.
Information provided by (Responsible Party):
Devin Brown, University of Michigan
Results First Submitted: June 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

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

3.  Secondary:   Barthel Index   [ 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
Attrition pre-randomization and while in randomized treatment led to small numbers.


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


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: K23NS051202 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: June 21, 2011
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013