Trial Outcomes & Findings for DeVilbiss AutoAdjust With SmartFlex Comparative Study (NCT NCT01203956)
NCT ID: NCT01203956
Last Updated: 2015-04-28
Results Overview
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
SmartFlex First, Then Standard
First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
|
Standard First, Then Smartflex
First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
|
|---|---|---|
|
First Two-week Period
STARTED
|
15
|
13
|
|
First Two-week Period
COMPLETED
|
15
|
13
|
|
First Two-week Period
NOT COMPLETED
|
0
|
0
|
|
Second Two-week Period
STARTED
|
15
|
13
|
|
Second Two-week Period
Attended Sleep Studies for 14 Nights
|
15
|
13
|
|
Second Two-week Period
COMPLETED
|
10
|
7
|
|
Second Two-week Period
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
SmartFlex First, Then Standard
First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
|
Standard First, Then Smartflex
First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
|
|---|---|---|
|
Second Two-week Period
Non-compliant: no evaluable results
|
5
|
6
|
Baseline Characteristics
DeVilbiss AutoAdjust With SmartFlex Comparative Study
Baseline characteristics by cohort
| Measure |
All Evaluable Subjects
n=17 Participants
All subjects completing both two-week periods of crossover study, with evaluable results for each period.
|
|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
AHI (apnea-hypopnea index)
|
39.8 events / hour
STANDARD_DEVIATION 21.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksNumber of apnea/hypopnea events per hour, measured by SmartLink component of device.
Outcome measures
| Measure |
SmartFlex
n=17 Participants
Used CPAP device with SmartFlex engaged, in either first or second two-week period.
|
Standard
n=17 Participants
Used CPAP device without SmartFlex engaged, in either first or second two-week period.
|
|---|---|---|
|
Apnea-hypopnea Index (AHI)
|
5.92 events / hour
Standard Deviation 3.75
|
5.56 events / hour
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: 2 weeksThe Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device
Outcome measures
Outcome data not reported
Adverse Events
SmartFlex
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SmartFlex
n=17 participants at risk
CPAP device used with SmartFlex engaged, either in first or second two-week period.
|
Standard
n=17 participants at risk
CPAP device used without SmartFlex engaged, either in first or second two-week period.
|
n=17 participants at risk
From data available it cannot be determined which mode the subject was using at the time of this event.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Uncomfortable breathing due to expiratory resistance
|
11.8%
2/17 • Number of events 2 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Mouth breathing which may worsen snoring or OSA
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
Ear and labyrinth disorders
Nasal, sinus or middle ear discomfort
|
0.00%
0/17 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Dry mouth
|
0.00%
0/17 • 4 weeks
|
11.8%
2/17 • Number of events 2 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Headache
|
0.00%
0/17 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
|
General disorders
Redness on bridge of nose
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Nausea
|
0.00%
0/17 • 4 weeks
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Hiatal hernia
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Jaw pain
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
|
General disorders
Pressure sore on bridge of nose
|
5.9%
1/17 • Number of events 1 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
0.00%
0/17 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place