Trial Outcomes & Findings for Sleep Apnea Treatment After Stroke (SATS) (NCT NCT00282815)
NCT ID: NCT00282815
Last Updated: 2013-03-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
3 months
Results posted on
2013-03-11
Participant Flow
Patients enrolled from inpatient neurology service.
Participant milestones
| Measure |
Active Continuous Positive Airway Pressure (CPAP)
|
Sham Continuous Positive Airway Pressure (CPAP)
Subtherapeutic CPAP
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Apnea Treatment After Stroke (SATS)
Baseline characteristics by cohort
| Measure |
Active Continuous Positive Airway Pressure (CPAP)
n=15 Participants
|
Sham Continuous Positive Airway Pressure (CPAP)
n=17 Participants
Subtherapeutic CPAP
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age Continuous
|
61 years
STANDARD_DEVIATION 16 • n=99 Participants
|
74 years
STANDARD_DEVIATION 16 • n=107 Participants
|
65 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data not available on one sham participant (lowering n from 11 to 10 in the shame group).
Outcome measures
| Measure |
Active CPAP
n=8 Participants
|
Sham CPAP
n=10 Participants
|
|---|---|---|
|
Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
|
53 Hours/participant
Interval 22.0 to 173.0
|
74 Hours/participant
Interval 17.0 to 94.0
|
PRIMARY outcome
Timeframe: 3 monthsPrespecified outcome.
Outcome measures
| Measure |
Active CPAP
n=32 Participants
|
Sham CPAP
|
|---|---|---|
|
Number of Subjects Who Withdraw From Study.
|
13 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsBarthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).
Outcome measures
| Measure |
Active CPAP
n=8 Participants
|
Sham CPAP
n=11 Participants
|
|---|---|---|
|
Barthel Index
|
95 units on a scale (range 0-100)
Interval 90.0 to 100.0
|
100 units on a scale (range 0-100)
Interval 95.0 to 100.0
|
Adverse Events
Active Continuous Positive Airway Pressure (CPAP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Continuous Positive Airway Pressure (CPAP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place