Trial Outcomes & Findings for Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) (NCT NCT03329352)
NCT ID: NCT03329352
Last Updated: 2021-11-10
Results Overview
Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
14 ± 5 days in-home
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
F&P Toffee Full-Face Mask
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3).
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|---|---|
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F&P Toffee Full Face Mask Validation
STARTED
|
44
|
|
F&P Toffee Full Face Mask Validation
COMPLETED
|
42
|
|
F&P Toffee Full Face Mask Validation
NOT COMPLETED
|
2
|
|
Extension
STARTED
|
29
|
|
Extension
COMPLETED
|
22
|
|
Extension
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Baseline characteristics by cohort
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee Full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-homeDetermined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
|
Trial Mask Comfort
Very comfortable
|
20 Participants
|
|
Trial Mask Comfort
Comfortable
|
16 Participants
|
|
Trial Mask Comfort
Neutral
|
4 Participants
|
|
Trial Mask Comfort
Uncomfortable
|
1 Participants
|
|
Trial Mask Comfort
Very uncomfortable
|
0 Participants
|
|
Trial Mask Comfort
N/A
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-homeDetermined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
|
Participant Count of Acceptable Trial Mask Performance - Objective
Pass
|
34 Participants
|
|
Participant Count of Acceptable Trial Mask Performance - Objective
Fail
|
0 Participants
|
|
Participant Count of Acceptable Trial Mask Performance - Objective
N/A
|
8 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-homeDetermined from questionnaire - Subjective Uses a 5 point Likert Scale
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
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Trial Mask Seal Performance - Subjective
Very good
|
17 Participants
|
|
Trial Mask Seal Performance - Subjective
Good
|
14 Participants
|
|
Trial Mask Seal Performance - Subjective
Neutral
|
4 Participants
|
|
Trial Mask Seal Performance - Subjective
Poor
|
4 Participants
|
|
Trial Mask Seal Performance - Subjective
Very poor
|
2 Participants
|
|
Trial Mask Seal Performance - Subjective
N/A
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-homeDetermined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
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Trial Mask Ease of Cleaning
Very easy
|
25 Participants
|
|
Trial Mask Ease of Cleaning
Easy
|
15 Participants
|
|
Trial Mask Ease of Cleaning
Neutral
|
2 Participants
|
|
Trial Mask Ease of Cleaning
Hard
|
0 Participants
|
|
Trial Mask Ease of Cleaning
Very hard
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-homeParticipants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
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Trial Mask Ease-of-use
Very easy
|
27 Participants
|
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Trial Mask Ease-of-use
Easy
|
14 Participants
|
|
Trial Mask Ease-of-use
Neutral
|
1 Participants
|
|
Trial Mask Ease-of-use
Hard
|
0 Participants
|
|
Trial Mask Ease-of-use
Very hard
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0 Participants
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SECONDARY outcome
Timeframe: 14 ± 5 days in-homeData recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not.
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=42 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
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Participant Count of Acceptable Mask Leak
Pass
|
30 Participants
|
|
Participant Count of Acceptable Mask Leak
Fail
|
4 Participants
|
|
Participant Count of Acceptable Mask Leak
N/A
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 day-time appointment (1 hour) Visit 2Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.
Outcome measures
| Measure |
F&P Toffee Full-Face Mask
n=44 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Toffee Full-Face Mask: The F\&P Toffee full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
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|---|---|
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Participant Count of Seal Size Determination
Pass
|
28 Participants
|
|
Participant Count of Seal Size Determination
Fail
|
16 Participants
|
Adverse Events
F&P Full-Face Mask
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
F&P Full-Face Mask
n=42 participants at risk
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Full-Face Mask: The F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
Adverse event data will be collated for both arms of the trial for simplicity.
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|---|---|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected over the 6 months the trial ran for (including the extension)
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected over the 6 months the trial ran for (including the extension)
|
Other adverse events
| Measure |
F&P Full-Face Mask
n=42 participants at risk
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F\&P Full-Face Mask: The F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
Adverse event data will be collated for both arms of the trial for simplicity.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Facial irritation
|
4.8%
2/42 • Number of events 2 • Adverse event data was collected over the 6 months the trial ran for (including the extension)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place