Trial Outcomes & Findings for The Role of Sleep Disordered Breathing in Heart Failure Admissions (NCT NCT02505867)
NCT ID: NCT02505867
Last Updated: 2019-06-11
Results Overview
Number of participant hospital readmissions
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Six Months
Results posted on
2019-06-11
Participant Flow
Participant milestones
| Measure |
Device - ASV Therapy
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
|
Control
No device provided
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Device - ASV Therapy
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
|
Control
No device provided
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
6
|
Baseline Characteristics
The Role of Sleep Disordered Breathing in Heart Failure Admissions
Baseline characteristics by cohort
| Measure |
Device - ASV Therapy
n=6 Participants
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
|
Control
n=6 Participants
No device provided
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.33 years
n=99 Participants
|
46.33 years
n=107 Participants
|
46.83 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Six MonthsNumber of participant hospital readmissions
Outcome measures
| Measure |
Device - ASV Therapy
n=6 Participants
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
Adaptive Servo Ventilation: Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
|
Control
n=6 Participants
No device provided
|
|---|---|---|
|
Hospital Readmissions
|
0 Participants
|
0 Participants
|
Adverse Events
Device - ASV Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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