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.
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. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ). Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask. Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.
Fisher & Paykel Healthcare
Auckland, New Zealand
Wellsleep: Bowen Hospital
Wellington, New Zealand
Objective mask leak data measurement (System Leak)
Obtained from participant's CPAP device, measured in L/min
Time frame: Up to 21 ± 6 days in-home
Subjective Measurement of leak assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Comfort assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Stability assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Draft assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Noise assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Preference of Mask assessed using a Subjective Questionnaire
Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Usability via mask unboxing/fitting exercise with a subjective questionnaire
Usability activity during visit 2 with subjective questionnaire after activity
Time frame: Up to 21 ± 6 days in-home
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