Trial Outcomes & Findings for F&P Toffee Full Face Mask Clinical Trial, NZ, 2020 (NCT NCT04615832)

Last Updated: 2021-12-01

Results Overview

To assess the comfort of the mask as experienced by the participant. Comfort will be measured on a 4 point likert type scale (options: Very Uncomfortable, Uncomfortable, Comfortable, and Very Comfortable). Very Comfortable will be scored the highest and Very Uncomfortable will be scored the lowest. Different aspects of the mask such as cushion comfort, headgear comfort and overall comfort will be assessed using the same scale. Questions will be asked on a questionnaire and further qualitative responses will be captured during an interview.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

Assessed 2 weeks after mask fitting

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Toffee Full Face Mask Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

F&P Toffee Full Face Mask Clinical Trial, NZ, 2020

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toffee Full Face Mask n=44 Participants Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment New Zealand	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed 2 weeks after mask fitting

Outcome measures

Outcome measures
Measure	Toffee Full Face Mask n=44 Participants Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Comfort - Subjective Very comfortable	18 Participants
Comfort - Subjective Comfortable	23 Participants
Comfort - Subjective Uncomfortable	2 Participants
Comfort - Subjective Very uncomfortable	1 Participants

PRIMARY outcome

Timeframe: Assessed 2 weeks after mask fitting

To assess the ease of use of the mask as experienced by the participant. Questions regarding the freedom of movement in bed will be asked using a 4 point likert type scale (options: Very Difficult, Difficult, Easy, and Very Easy). Very Easy will be scored the highest and Very Difficult will be scored the lowest. Questions will be asked via a questionnaire with additional qualitative responses captured during an interview.

Outcome measures

Outcome measures
Measure	Toffee Full Face Mask n=44 Participants Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Usability Very easy	19 Participants
Usability Easy	23 Participants
Usability Difficult	2 Participants
Usability Very difficult	0 Participants

PRIMARY outcome

Timeframe: Assessed 2 weeks after mask fitting

To assess the sealing performance of the mask when used in a home environment. Questions regarding the seal performance will be asked using a 4 point likert type scale (options: Very poor, Poor, Good, and Very good). Very good will be scored the highest and Very poor will be scored the lowest.

Outcome measures

Outcome measures
Measure	Toffee Full Face Mask n=44 Participants Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Seal Performance Good	15 Participants
Seal Performance Very good	25 Participants
Seal Performance Poor	4 Participants
Seal Performance Very poor	0 Participants

Adverse Events

Toffee Full Face Mask

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Toffee Full Face Mask n=44 participants at risk Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment
Injury, poisoning and procedural complications Nasal soreness	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Injury, poisoning and procedural complications Broken ankle	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Respiratory, thoracic and mediastinal disorders Nasal compression	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Injury, poisoning and procedural complications Knee pain	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Injury, poisoning and procedural complications Left shoulder pain	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Respiratory, thoracic and mediastinal disorders Nose bleed	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Eye disorders Eye irritation	4.5% 2/44 • Number of events 2 • Adverse event data was collected during the 2 week duration of the study period.
Psychiatric disorders Mouth abscess	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.
Gastrointestinal disorders Mouth Ulcer	2.3% 1/44 • Number of events 1 • Adverse event data was collected during the 2 week duration of the study period.

Additional Information

Bhavi Ogra

Fisher & Paykel Healthcare Ltd.

Phone: +64 9 574 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place