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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Scientific title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 0 0
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Study type
Description of intervention(s) / exposure
Treatment: Devices - F&P nasal mask

Experimental: F&P Nasal Mask - Trial nasal pillows CPAP mask

Treatment: Devices: F&P nasal mask
Investigative Nasal Mask to be used for OSA therapy

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Ease of use - Subjective questionnaire
Timepoint [1] 0 0
1 night
Primary outcome [2] 0 0
Acceptability - Subjective questionnaire
Timepoint [2] 0 0
1 night
Secondary outcome [1] 0 0
Objective leak data - Data obtained from participant's device - Objective
Timepoint [1] 0 0
1 night

Key inclusion criteria
- Adult (18+ years of age)

- Able to give consent

- Apnea hypopnea Index (AHI)= 5 on diagnostic night

- Prescribed PAP for OSA

- Existing nasal mask user
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Inability to give consent

- Patients who are in a coma or a decreased level of consciousness

- Anatomical or physiological conditions making automatic positive airway pressure
(APAP) therapy inappropriate (e.g. unconsolidated facial structure)

- Commercial drivers who are investigated by New Zealand Transport Agency

- Current diagnosis of carbon dioxide (CO2) retention

- Pregnant or may think they are pregnant

Study design
Purpose of the study
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

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

Ethics approval
Ethics application status

Brief summary
This investigation is designed to evaluate the performance as well as the patients overall
acceptance of the mask.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Sarah Gunson
Address 0 0
Sponsor Employee
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

Summary results
Other publications