Each participant will wear a wearable PAP device, tethered to a released PAP device for up to 7 nights. Objectives include collecting and evaluating participants feedback on seal, comfort and usability of the wearable PAP device.
The wearable PAP study evaluates the APL mask system, a wearable PAP interface concept designed to explore alternative form factors that may improve comfort, wearability, and user acceptance of PAP therapy. This study aims to generate early human-use insights on the APL mask system when used in a tethered configuration with a commercially available PAP device, to inform design refinement. The study will follow a phased approach, enrolling small cohorts of participants per phase. The study population includes internal participants (Resmed employees, with and without OSA) and external participants with diagnosed OSA who are established PAP users. Approximately 5-15 participants will be enrolled per phase. Participants who meet the inclusion criteria, and whom provide written consent, will attend an in-person visit, followed by up to seven consecutive nights of at-home use of the APL mask system. The participants will complete a questionnaire following use of the device, before returning equipment in a second visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The investigational intervention is the APL mask system, consisting of a nasal mask cushion integrated into a weighted eye mask and headgear. The system is used in a tethered configuration via a released AirFit™ N20 short tube elbow and AirSense™ 11 ClimateLine™ tubing to a commercially available Resmed AirSense™ 11 PAP therapy device.
Subjective usability and overnight acceptability
The primary endpoint of this study is subjective usability and overnight acceptability of the APL mask system, focusing on comfort, seal, stability, perceived weight and wearability during sleep. Participants will complete a structured questionnaire using an 11-point Likert scale (0 = very unfavourable, 10 = very favourable). These responses will be used to characterise the overall user experience and identify areas for design refinement.
Time frame: 7 nights
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