Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04615832




Registration number
NCT04615832
Ethics application status
Date submitted
28/10/2020
Date registered
4/11/2020
Date last updated
1/12/2021

Titles & IDs
Public title
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Scientific title
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Secondary ID [1] 0 0
CIA-284
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positive Airway Pressure Therapy 0 0
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Toffee Full Face Mask

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


Treatment: Devices: Toffee Full Face Mask
Full face mask for PAP therapy applied in a home environment
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comfort - Subjective
Timepoint [1] 0 0
Assessed 2 weeks after mask fitting
Primary outcome [2] 0 0
Usability
Timepoint [2] 0 0
Assessed 2 weeks after mask fitting
Primary outcome [3] 0 0
Seal Performance
Timepoint [3] 0 0
Assessed 2 weeks after mask fitting

Eligibility
Key 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
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2021
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hawkes Bay
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04615832
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra
Address 0 0
Fisher & Paykel Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries