Evaluation of the Feasibility, Usability and Short-Term Tolerability of a Prototype Wearable Positive Airway Pressure (PAP) Device During a Supervised Daytime Nap
Evaluation of the Feasibility, Usability and Short-Term Tolerability of a Prototype Wearable Positive Airway Pressure (PAP) Device During a Supervised Daytime Nap
This exploratory pilot study will evaluate the usability and short-term tolerability of the APL wearable positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment. The study is designed to assess participant experience with the investigational wearable PAP device, including comfort, fit and seal, perceived weight, ease of use, and ability to fall asleep while using the device.
Participants will attend a supervised PAP-Nap session where they will use the wearable PAP device while resting or attempting to sleep. Study staff will also observe sleep-related behaviours, including sleep onset and session completion. Information collected from this study will help inform future development and refinement of wearable PAP technologies intended for the treatment of obstructive sleep apnea (OSA).
Inclusion Criteria:
Exclusion Criteria:
alisha.middleton@resmed.com.au+61422514889
This exploratory pilot clinical investigation is designed to evaluate the usability and short-term tolerability of the investigational APL wearable positive airway pressure (PAP) device during a supervised daytime nap session in adults with obstructive sleep apnea (OSA) who are established continuous positive airway pressure (CPAP) users. The study focuses on early-stage human factors and usability assessment to support iterative device development and future clinical investigation planning.
Approximately 10-15 adult participants with diagnosed OSA who are currently using CPAP therapy will attend a single supervised in-clinic visit in a simulated bedroom environment. Participants will undergo device fitting and instruction before attempting a daytime nap of up to 90 minutes using the investigational device. During the session, trained study personnel will monitor participant safety and device performance through direct and/or remote observation.
The primary evaluation focuses on participant-reported usability outcomes, including comfort, seal, perceived weight, and ease of use. Secondary and exploratory assessments include ability to initiate sleep while using the device, observed sleep-related behaviours, session completion, tolerability, and descriptive sleep-related data collected from a contactless under-mattress monitoring device. Data collected from this study are intended to support design refinement, usability optimisation, and planning of future clinical studies involving wearable PAP technologies.