Trial Outcomes & Findings for Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease (NCT NCT00984308)
NCT ID: NCT00984308
Last Updated: 2017-06-14
Results Overview
The number of patients with a diagnosis of sleep apnea
COMPLETED
PHASE2/PHASE3
225 participants
The entire study period (baseline and up to one-year)
2017-06-14
Participant Flow
Participant milestones
| Measure |
Intervention
The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
|
Control
The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
115
|
|
Overall Study
COMPLETED
|
92
|
109
|
|
Overall Study
NOT COMPLETED
|
18
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease
Baseline characteristics by cohort
| Measure |
Intervention
n=110 Participants
|
Control
n=115 Participants
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
70.2 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
70 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: The entire study period (baseline and up to one-year)Population: The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.
The number of patients with a diagnosis of sleep apnea
Outcome measures
| Measure |
Intervention
n=102 Participants
|
Control
n=7 Participants
|
|---|---|---|
|
Sleep Apnea Diagnosis Rate
|
58 participants
|
5 participants
|
PRIMARY outcome
Timeframe: One yearPopulation: ITT
Medication-Adjusted Systolic Blood Pressure
Outcome measures
| Measure |
Intervention
n=110 Participants
|
Control
n=115 Participants
|
|---|---|---|
|
Hypertension Control
|
157.4 mm Hg
Standard Deviation 25
|
161.6 mm Hg
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: One yearPopulation: Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.
Outcome measures
| Measure |
Intervention
n=57 Participants
|
Control
n=2 Participants
|
|---|---|---|
|
Sleep Apnea Treatment Rate
|
22 participants
|
0 participants
|
Adverse Events
Intervention
Control
Serious adverse events
| Measure |
Intervention
n=110 participants at risk
|
Control
n=115 participants at risk
|
|---|---|---|
|
Nervous system disorders
stroke
|
0.00%
0/110
|
0.87%
1/115 • Number of events 1
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.91%
1/110 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Cardiac disorders
Congestive heart failure (CHF)
|
2.7%
3/110 • Number of events 3
|
0.00%
0/115
|
|
Cardiac disorders
Acute myocardial infarction (AMI)
|
0.00%
0/110
|
0.00%
0/115
|
|
General disorders
DEATH
|
0.91%
1/110 • Number of events 1
|
0.00%
0/115
|
Other adverse events
| Measure |
Intervention
n=110 participants at risk
|
Control
n=115 participants at risk
|
|---|---|---|
|
General disorders
Falls
|
20.0%
22/110 • Number of events 22
|
26.1%
30/115 • Number of events 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place