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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/NCT02938208
Registration number
NCT02938208
Ethics application status
Date submitted
16/10/2016
Date registered
19/10/2016
Date last updated
25/07/2017
Titles & IDs
Public title
An Investigation to Test a Prototype Full-face Mask in the Home Setting
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Scientific title
An Investigation to Test a Prototype Full-face Mask in the Home Setting
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Secondary ID [1]
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CIA-198
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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:
Sleep Disordered Breathing
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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 - Jupiter Full Face Mask
Experimental: Jupiter Full Face Mask - Participants to use full face mask in-home for a 14 ± 3 days in-home.
Treatment: Devices: Jupiter Full Face Mask
Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.
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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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Objective mask leak data measurement (System Leak)
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Assessment method [1]
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Obtained from participant's CPAP device, measured in L/min
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Timepoint [1]
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Up to 21 ± 6 days in-home
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Primary outcome [2]
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Subjective Measurement of leak assessed using a Subjective Questionnaire
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Assessment method [2]
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Subjective Questionnaire
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Timepoint [2]
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Up to 21 ± 6 days in-home
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Primary outcome [3]
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Comfort assessed using a Subjective Questionnaire
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Assessment method [3]
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Subjective Questionnaire
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Timepoint [3]
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Up to 21 ± 6 days in-home
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Primary outcome [4]
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Stability assessed using a Subjective Questionnaire
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Assessment method [4]
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Subjective Questionnaire
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Timepoint [4]
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Up to 21 ± 6 days in-home
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Primary outcome [5]
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Draft assessed using a Subjective Questionnaire
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Assessment method [5]
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Subjective Questionnaire
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Timepoint [5]
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Up to 21 ± 6 days in-home
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Primary outcome [6]
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Noise assessed using a Subjective Questionnaire
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Assessment method [6]
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Subjective Questionnaire
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Timepoint [6]
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Up to 21 ± 6 days in-home
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Secondary outcome [1]
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Preference of Mask assessed using a Subjective Questionnaire
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Assessment method [1]
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Subjective Questionnaire
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Timepoint [1]
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Up to 21 ± 6 days in-home
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Secondary outcome [2]
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Usability via mask unboxing/fitting exercise with a subjective questionnaire
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Assessment method [2]
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Usability activity during visit 2 with subjective questionnaire after activity
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Timepoint [2]
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Up to 21 ± 6 days in-home
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Eligibility
Key inclusion criteria
Inclusion Criteria
- 18+ years of age
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or
Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or
experienced (6 months and more)
- Existing full face mask users
- Patients who are able to put on and remove their current mask without gross difficulty
relating to an existing condition (e.g. arthritis of the hands).
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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?
No
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Key exclusion criteria
Exclusion Criteria
- Inability to give informed consent
- Anatomical or physiological conditions making PAP therapy inappropriate (e.g
unconsolidated facial fracture)
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of 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
N/A
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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
Single group
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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
3/11/2016
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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
31/05/2017
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Sample size
Target
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Accrual to date
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Final
14
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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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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Wellington
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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
This investigation is a prospective non-blinded and non-randomized clinical investigation.
This investigation is designed to evaluate the performance (leak and comfort) as well as
participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number
of up to 15 OSA participants who currently use full face masks will be recruited for the
trial.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02938208
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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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Kayan Gonda, BSc
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Address
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Sponsor Employee
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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/NCT02938208
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