Clinical trial NCT04615832: F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Official title: F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive Airway Pressure Therapy
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comfort - Subjective
timeFrame: Assessed 2 weeks after mask fitting
measure: Usability
timeFrame: Assessed 2 weeks after mask fitting
measure: Seal Performance
timeFrame: Assessed 2 weeks after mask fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Hastings
country: New Zealand
facility: Hastings Memorial Hospital
state: Hawkes Bay
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
city: Wellington
country: New Zealand
facility: Bowen Hospital
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Bhavi Ogra
role: PRINCIPAL_INVESTIGATOR
References: