A study on the Bonsai Sensor on participants with or without Obstructive Sleep Apnoea (OSA) to assess signal parameters

The Bonsai system consists of a small sensor device which is placed on the fingertip, the Bonsai Sensor, and a cloud-based analytics platform, the Bonsai software. The Bonsai system is able to derive diagnostic parameters recommended by The AASM Manual for the Scoring of Sleep and Associated Events for home sleep apnea testing utilizing peripheral arterial tonometry and was validated against in-laboratory polysomnography (PSG). The purpose of this protocol is to assess the Bonsai Sensor signal parameters and may compare different builds or design iterations. For the purpose of this study the Bonsai sensors are not used to screen nor diagnose Obstructive Sleep Apnoea (OSA). One build of the sensor may be sampled and evaluated for each sub-study. Alternatively, a sub-study may compare sensors sampled from different build or design iterations. If different builds or iterations are tested in the same sub-study the participants will wear the different types on the same hand (e.g. one on the middle finger and another type on the index finger). Alternatively, the same test protocol may be repeated for different builds. Each sub-study protocol will determine the need for assessing specific build(s)/design iteration (e.g. extent of design modification). Examples of different builds/design iterations to be assessed may include newly commissioned manufacturing lines, new vendors for parts supplied or minor change in manufacturing processes or design of specific parts. The engineering team will assess the extent of the impact and need for testing on participants in addition to engineering bench testing. The way the participants are required to apply or use the device is not expected to be different in sub-protocols. Each participant will apply 2 sensors to the same hand, one on the index finger and one on the middle finger of the left or right hand, and connect each sensor to the Bonsai smartphone app to perform overnight recordings. Each participant will test a total of 6 sensors over 3 nights. Recorded data will be analysed by the currently released algorithm. In the case of unsuccessful recordings, participants will be asked to try to repeat the recordings for additional 2 nights maximum. Instructions will be provided to the participants via the smartphone app and the study specific instructions sheet. Sub-studies under this protocol are estimated to be run for 4-8 weeks from recruitment to all participants completing the sub-study. This study is going to be conducted remotely or face to face by Medical Affairs department of ResMed, with recruitment activities run across Australia. Participants with or without diagnosis of Obstructive Sleep Apnoea will be screened and enrolled. Participants may take part in multiple sub-studies however will not be asked to use the sensor for more than 5 nights consecutively (i.e.., the involvement in 2 sub-studies will not be one after the other without a break in between).