Positive Airway Pressure TherapyNCT04615832
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
A study testing Toffee Full Face Mask in people with Positive Airway Pressure Therapy and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Positive Airway Pressure Therapy, Obstructive Sleep Apnea
- What is being tested?
- Toffee Full Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesNew Zealand
- Study dates
- 10 Nov 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
New Zealand3 sites
Fisher & Paykel Healthcare
Auckland, 2013
Hastings Memorial Hospital
Hastings, Hawkes Bay, 1420
Bowen Hospital
Wellington, 6035
About this study
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.
Read the 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.
- Being tested
- Toffee Full Face Mask
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toffee Full Face MaskDevice
Full face mask for PAP therapy applied in a home environment
| Study group | Role | What they receive |
|---|---|---|
| Toffee Full Face Mask | Experimental | Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. Receives: Device: Toffee Full Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed 2 weeks after mask fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Nov 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Positive Airway Pressure TherapyStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavi Ogra, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615832
- Sponsor's protocol ID
- CIA-284
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2020
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
- ClinicalTrials.gov ID
- NCT04615832
- Acronym / sponsor ID
- CIA-284
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toffee Full Face Mask | Experimental | Device: Toffee Full Face MaskToffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toffee Full Face MaskFull face mask for PAP therapy applied in a home environment | Device | Toffee Full Face Mask |
Primary outcome
Comfort - Subjective
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavi Ogra principal investigator
Fisher & Paykel Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toffee Full Face Mask in people with Positive Airway Pressure Therapy and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort - Subjective (time frame: Assessed 2 weeks after mask fitting). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.