Obstructive Sleep Apnea Clinical Trial
Official title:
An Investigation to Test a Prototype Full-face Mask in the Home Setting
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.
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