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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02297789




Registration number
NCT02297789
Ethics application status
Date submitted
19/11/2014
Date registered
21/11/2014
Date last updated
24/07/2015

Titles & IDs
Public title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Scientific title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
CIA-152
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Investigative Full Face Mask with Headgear

Experimental: Headgear 1 - Full Face Mask with Headgear 1

Experimental: Headgear 2 - Full Face Mask with Headgear 2


Treatment: Devices: Investigative Full Face Mask with Headgear


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

Outcomes
Primary outcome [1] 0 0
The mask is comfortable and is effective for the participant during in-home use - Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.
Timepoint [1] 0 0
1 week for each mask prototype in-home
Secondary outcome [1] 0 0
Acceptability of the Full Face mask prototypes - Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log
Timepoint [1] 0 0
1 week for each mask prototype in-home

Eligibility
Key inclusion criteria
- AHI = 5 from the diagnostic night

- = 18 years of age

- Either prescribed APAP or CPAP or Bi level for OSA

- Existing full face users
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to give informed consent

- Participant intolerance to PAP

- Anatomical or physiological conditions making PAP therapy inappropriate

- Current diagnosis of respiratory disease or CO2 retention

- Pregnant or think they may be pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Crossover
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
East Tamaki

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

Ethics approval
Ethics application status

Summary
Brief summary
Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective
of this clinical investigation is to evaluate the usability and acceptance of the
investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according
to the randomization log for 7 ± 3 days in home. The participant will then crossover to the
other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or
the participants will be blinded to the study.
Trial website
https://clinicaltrials.gov/show/NCT02297789
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra, BSc
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

Summary results
Other publications