Obstructive Sleep Apnea Clinical Trial
Official title:
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
This investigation is designed to evaluate the performance (treatment and leak), comfort
(subjective feedback), stability (subjective feedback, leak) as well as the participant's
overall acceptance of the Saturn mask amongst OSA participants. An important factor in this
investigation will be the testing of our two different seal sizes on the participants (small
and medium size). A total number of 15 participants who currently use nasal or nasal pillow
masks will be recruited for the trial. A subset of participants have been selected based on
their anthropometric measurements collected in previous trials using nasal and nasal pillow
masks at this site (CIA-103). Participants from previous NZ trials may be recruited into
this trial with their consent. All the participants will be recruited by WellSleep,
Wellington.
Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will
be collected from the participant during the first visit, the prior 7 days of CPAP usage
data will be downloaded and stored for our analysis. The participant will use the trial
device on their usual CPAP/APAP setting and device for the duration of the trial.
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 as soon as possible.
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