Obstructive Sleep Apnea Clinical Trial
Official title:
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance (leak and comfort) as well as the
participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea
(OSA) participants. An important factor in this investigation will be the testing of two
different seal sizes on the participants (medium and large size). A total number of 12
participants who currently use nasal or nasal pillow masks will be recruited for the trial.
Participants have been selected based on their anthropometric measurements collected in
previous trials (CIA-103). Participants from previous NZ trials may be recruited into this
trial with their consent. All the participants will be recruited from the Fisher & Paykel
Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District
Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight
polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be
collected from the participant during the first visit, 7 days of CPAP usage data will be
downloaded and stored for analysis. The participant will use the trial device on their usual
Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration
of the trial.
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