Trial Outcomes & Findings for The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ (NCT NCT02741635)
NCT ID: NCT02741635
Last Updated: 2024-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
12 hours
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Toffee Nasal Pillows Mask
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Toffee Nasal Pillows Mask
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Baseline characteristics by cohort
| Measure |
Toffee Nasal Pillows Mask
n=15 Participants
Participants to use nasal pillows mask one night in lab overnight polysomnography.
Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Age, Customized
18+ years of age
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hoursOutcome measures
| Measure |
Toffee Nasal Pillows Mask
n=14 Participants
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 hoursOutcome measures
| Measure |
Toffee Nasal Pillows Mask
n=14 Participants
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 hoursOutcome measures
| Measure |
Toffee Nasal Pillows Mask
n=14 Participants
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
|
|---|---|
|
Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask
|
8 Participants
|
Adverse Events
Toffee Nasal Pillows Mask
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