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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
An Investigation to Test a Prototype Full-face Mask in the Home Setting
Secondary ID [1] 0 0
CIA-198
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

Intervention/exposure
Study type
Interventional
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.

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

Outcomes
Primary outcome [1] 0 0
Objective mask leak data measurement (System Leak) - Obtained from participant's CPAP device, measured in L/min
Timepoint [1] 0 0
Up to 21 ± 6 days in-home
Primary outcome [2] 0 0
Subjective Measurement of leak assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [2] 0 0
Up to 21 ± 6 days in-home
Primary outcome [3] 0 0
Comfort assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [3] 0 0
Up to 21 ± 6 days in-home
Primary outcome [4] 0 0
Stability assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [4] 0 0
Up to 21 ± 6 days in-home
Primary outcome [5] 0 0
Draft assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [5] 0 0
Up to 21 ± 6 days in-home
Primary outcome [6] 0 0
Noise assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [6] 0 0
Up to 21 ± 6 days in-home
Secondary outcome [1] 0 0
Preference of Mask assessed using a Subjective Questionnaire - Subjective Questionnaire
Timepoint [1] 0 0
Up to 21 ± 6 days in-home
Secondary outcome [2] 0 0
Usability via mask unboxing/fitting exercise with a subjective questionnaire - Usability activity during visit 2 with subjective questionnaire after activity
Timepoint [2] 0 0
Up to 21 ± 6 days in-home

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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
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
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
Auckland
Country [2] 0 0
New Zealand
State/province [2] 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
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.
Trial website
https://clinicaltrials.gov/show/NCT02938208
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kayan Gonda, BSc
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