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Sleep Apnea Treatment After Stroke (SATS)

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.
 
ClinicalTrials.gov Identifier: NCT00282815
Recruitment Status : Terminated (Poor recruitment. Funding expired.)
First Posted : January 27, 2006
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan

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
Enrollment 32
Recruitment Details Patients enrolled from inpatient neurology service.
Pre-assignment Details  
Arm/Group Title Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Hide Arm/Group Description [Not Specified] Subtherapeutic CPAP
Period Title: Overall Study
Started 15 17
Completed 8 11
Not Completed 7 6
Arm/Group Title Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP) Total
Hide Arm/Group Description [Not Specified] Subtherapeutic CPAP Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  53.3%
5
  29.4%
13
  40.6%
>=65 years
7
  46.7%
12
  70.6%
19
  59.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
61  (16) 74  (16) 65  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
10
  66.7%
4
  23.5%
14
  43.8%
Male
5
  33.3%
13
  76.5%
18
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 32 participants
15 17 32
1.Primary Outcome
Title Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available on one sham participant (lowering n from 11 to 10 in the shame group).
Arm/Group Title Active CPAP Sham CPAP
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 10
Median (Inter-Quartile Range)
Unit of Measure: Hours/participant
53
(22 to 173)
74
(17 to 94)
2.Primary Outcome
Title Number of Subjects Who Withdraw From Study.
Hide Description Prespecified outcome.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title After Randomization
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
13
3.Secondary Outcome
Title Barthel Index
Hide Description Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Hide Arm/Group Description:
[Not Specified]
Subtherapeutic CPAP
Overall Number of Participants Analyzed 8 11
Median (Inter-Quartile Range)
Unit of Measure: units on a scale (range 0-100)
95
(90 to 100)
100
(95 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Hide Arm/Group Description [Not Specified] Subtherapeutic CPAP
All-Cause Mortality
Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Continuous Positive Airway Pressure (CPAP) Sham Continuous Positive Airway Pressure (CPAP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Attrition pre-randomization and while in randomized treatment led to small numbers.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Devin Brown, MD
Organization: University of Michigan
Phone: 734-936-9075
EMail: devinb@umich.edu
Layout table for additonal information
Responsible Party: Devin Brown, University of Michigan
ClinicalTrials.gov Identifier: NCT00282815    
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