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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04615832
Ethics application status
Date submitted
28/10/2020
Date registered
4/11/2020

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
Not applicable
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04615832