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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
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Secondary ID [1]
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CIA-152
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The mask is comfortable and is effective for the participant during in-home use
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Assessment method [1]
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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.
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Timepoint [1]
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1 week for each mask prototype in-home
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Secondary outcome [1]
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Acceptability of the Full Face mask prototypes
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Assessment method [1]
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Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log
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Timepoint [1]
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1 week for each mask prototype in-home
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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East Tamaki
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Fisher and Paykel Healthcare
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02297789
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bhavi Ogra, BSc
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Address
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Fisher & Paykel Healthcare
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02297789
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