Trial Outcomes & Findings for A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT03272763)
NCT ID: NCT03272763
Last Updated: 2022-06-21
Results Overview
Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
14 ± 5 days In-Home
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
F&P Toffee Mask
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Overall Study
STARTED
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38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
|
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Age, Categorical
Between 18 and 65 years
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38 Participants
n=93 Participants
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Age, Categorical
>=65 years
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0 Participants
n=93 Participants
|
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Sex: Female, Male
Female
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16 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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22 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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34 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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38 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeComfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Trial Mask Comfort
Much better
|
7 Participants
|
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Trial Mask Comfort
Better
|
13 Participants
|
|
Trial Mask Comfort
Same
|
3 Participants
|
|
Trial Mask Comfort
Worse
|
12 Participants
|
|
Trial Mask Comfort
Much worse
|
3 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomePerformance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Trial Mask Performance - Objective
Increased leak
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9 Participants
|
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Trial Mask Performance - Objective
Same leak
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3 Participants
|
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Trial Mask Performance - Objective
Decreased leak
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9 Participants
|
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Trial Mask Performance - Objective
N/A
|
17 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeSeal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
|
|---|---|
|
Trial Mask Performance - Subjective
Much better
|
9 Participants
|
|
Trial Mask Performance - Subjective
Better
|
8 Participants
|
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Trial Mask Performance - Subjective
Same
|
10 Participants
|
|
Trial Mask Performance - Subjective
Worse
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10 Participants
|
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Trial Mask Performance - Subjective
Much worse
|
1 Participants
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PRIMARY outcome
Timeframe: During Visit Two - 20 minutesWhether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Trial Mask Usability
Both orientation and positioning
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17 Participants
|
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Trial Mask Usability
Orientation only
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25 Participants
|
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Trial Mask Usability
Neither
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1 Participants
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PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeUsability of trial mask compared to usual mask. Determined from questionnaires - Subjective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
|
|---|---|
|
Trial Mask Ease-of-Use
Much better
|
7 Participants
|
|
Trial Mask Ease-of-Use
Better
|
14 Participants
|
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Trial Mask Ease-of-Use
Same
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13 Participants
|
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Trial Mask Ease-of-Use
Worse
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3 Participants
|
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Trial Mask Ease-of-Use
Much worse
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1 Participants
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SECONDARY outcome
Timeframe: 14 ± 5 days In-HomeLeak data recorded from PAP device - Objective
Outcome measures
| Measure |
F&P Toffee Mask
n=20 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Mask Leak Data
Leak increased
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1 Participants
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Mask Leak Data
Leak remained the same
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3 Participants
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Mask Leak Data
Leak decreased
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10 Participants
|
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Mask Leak Data
No data
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6 Participants
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SECONDARY outcome
Timeframe: 1 day-time appointment (1 hour) during Visit TwoDid the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Seal Size Determination
Yes
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36 Participants
|
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Seal Size Determination
No
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2 Participants
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SECONDARY outcome
Timeframe: 14 ± 5 days In-HomeAHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
Outcome measures
| Measure |
F&P Toffee Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
|
|---|---|
|
Efficacy Data
AHI increased
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18 Participants
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Efficacy Data
AHI remained the same
|
3 Participants
|
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Efficacy Data
AHI decreased
|
14 Participants
|
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Efficacy Data
No data
|
3 Participants
|
Adverse Events
F&P Toffee Mask
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
F&P Toffee Mask
n=38 participants at risk
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F\&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Nasal congestion and sore
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place