None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is associated with increased risk of cardiovascular disease including hypertension, and screening for this condition and treatment may help reduce those risks. Furthermore, undiagnosed OSA is also linked to increased risk of postoperative complications in patients undergoing major surgery. Opportunities to screen using simplified diagnostic devices may be an important approach to addressing this clinical burden. Conventionally, the diagnosis of OSA is conducted by laboratory polysomnography (PSG) . A number of simplified devices are emerging commercially including single use disposable single or dual channel home monitoring. Single use disposable devices may emerge as the most convenient method for screening for OSA, especially in the home setting, however formal validation against PSG has not been previosly performed. The NightOwl is a small dual channel device that acquires data from a single fingertip and is now TGA registered as a single-use device in addition to a previously validated reusable option. The purpose of this study is to validate the single-use NightOwl compared to its reusable counterpart and the gold standard laboratory PSG for the diagnosis of OSA. Findings of this study will inform models of care that may include screening for OSA. This may be important in the clinical assessment of operative risk in those suspected of OSA undergoing major surgery.
Interventions
Prospective cohort study of consecutive eligible patients undergoing clinically indicated in-laboratory polysomnography (PSG). Observation is using a NightOwl device to record accelerometer and photoplethysmography data to compare with in-laboratory PSG on the same participant. These recordings will occur concurrently.
Each participant will be connected to the standard in-laboratory sleep test equipment and then will have a NightOwl device applied to two fingers on their non-dominant hand - one
Prospective cohort study of consecutive eligible patients undergoing clinically indicated in-laboratory polysomnography (PSG). Observation is using a NightOwl device to record accelerometer and photoplethysmography data to compare with in-laboratory PSG on the same participant. These recordings will occur concurrently. Each participant will be connected to the standard in-laboratory sleep test equipment and then will have a NightOwl device applied to two fingers on their non-dominant hand - one reusable NightOwl and one disposable NightOwl. Testing will only be completed on the night of their scheduled in-laboratory sleep study and study participation is only for this time. There is no ongoing follow-up. The study session is supervised by the sleep scientist conducting the sleep study. No training for study participants is required.
Sponsors
A/Prof Darren Mansfield
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Participants aged between the ages of 18-85 undergoing diagnostic laboratory polysomnoagraphy being tested for the diagnosis of obstructive sleep apnoea.
Exclusion criteria
Patient's with a known diagnosis of obstructive sleep apnoea undergoing a treatment sleep study Participants unable to provide informed consent Studies with a total sleep time of less than 4 hours
Outcome results
None listed