Trial Outcomes & Findings for Nasal Pillows vs. Nasal Masks at High CPAP Pressure (NCT NCT01690923)
NCT ID: NCT01690923
Last Updated: 2014-10-08
Results Overview
AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
7 days
Results posted on
2014-10-08
Participant Flow
Participants recruited from ResMed Science Centre, Sydney, between Aug 2011 and Aug 2012
Participant milestones
| Measure |
Nasal Mask First, Then Pillows Mask
Sequence 1: Nasal mask first, then Pillows mask
\[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)\]
|
Pillows Mask First, Then Nasal Mask
Sequence 2: Pillows mask first, then Nasal mask
\[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)\]
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Baseline characteristics by cohort
| Measure |
Current CPAP Users
n=20 Participants
Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysAHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
Outcome measures
| Measure |
Current CPAP Users
n=20 Participants
Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)
|
|---|---|
|
AHI on Nasal Mask and Pillows Mask
AHI on nasal mask
|
1.7 events/hour
Standard Deviation 1.1
|
|
AHI on Nasal Mask and Pillows Mask
AHI on Nasal pillows
|
1.9 events/hour
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: After 7 days of useParticipant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
Outcome measures
| Measure |
Current CPAP Users
n=20 Participants
Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX)
|
|---|---|
|
Usability
Subjective Scores Overall Performance-Nasal Mask
|
8.0 Units on a scale
Interval 7.25 to 9.75
|
|
Usability
Subjective Scores Overall Performance-Nasal Pillow
|
8.5 Units on a scale
Interval 7.0 to 9.0
|
Adverse Events
Current CPAP Users
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