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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Positive Airway Pressure Therapy, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Toffee Full Face Mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toffee Full Face Mask<br>Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. | Device: Toffee Full Face Mask<br>* Full face mask for PAP therapy applied in a home environment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort - Subjective | 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. | Assessed 2 weeks after mask fitting | 
| Usability | 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. | Assessed 2 weeks after mask fitting | 
| Seal Performance | 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. | Assessed 2 weeks after mask fitting |