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

Not Applicable

Completed

Brief Summary: This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.

Detailed Description: The purpose of this clinical investigation was to evaluate the performance, comfort and ease of use of the F\&P Toffee Full Face Mask. The clinical investigation took place across three sites in order to recruit the required number of participants. The clinical investigation tested the mask on 44 participants, who were currently using a full face mask for PAP therapy.

This was a non-randomized non-blinded single intervention study. Informed consent was gathered from the 44 participants before demographic and baseline measurements were recorded. Participants were issued an appropriate fitting Toffee Full face mask for the two week at home trial.

After two weeks the participants returned the masks. At this visit device data was downloaded and participant questionnaires were completed.

Recruitment & Eligibility

Inclusion Criteria

Persons who are ≥ 22 years of age
Persons who weigh ≥ 66 lbs (30 kgs)
Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
Persons who are currently using a full face mask
Persons who have an IPAP pressure of < 30 cmH2O
Persons who currently use a PAP therapy device with data recording capabilities
Persons who are fluent in spoken and written English
Persons who possess the capacity to provide informed consent

Exclusion Criteria

Persons who are intolerant to PAP therapy
Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
Persons using nasal or nasal pillows masks
Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
Persons who are pregnant or think they may be pregnant
Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
Persons who currently have cold or flu like symptoms at the time of recruitment
Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment

Arm && Interventions

Group	Intervention	Description
Toffee Full Face Mask	Toffee Full Face Mask	Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Comfort - Subjective	Assessed 2 weeks after mask fitting	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.
Usability	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.
Seal Performance	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Hastings Memorial Hospital
🇳🇿
Hastings, Hawkes Bay, New Zealand
Fisher & Paykel Healthcare
🇳🇿
Auckland, New Zealand
Bowen Hospital
🇳🇿
Wellington, New Zealand