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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Positive Airway Pressure Therapy; Obstructive Sleep Apnea

Treatments: Device: Toffee Full Face Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT04615832

CIA-284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Toffee Full Face Mask

Experimental group

Description:

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

Treatment:

Device: Toffee Full Face Mask