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.
Participants who ≥ 18 years of age
Participants who can trial the APL mask system for up to 7 nights
Participants willing and able to complete the specified tasks
Participants being treated for Obstructive Sleep Apnea (OSA) for ≥ 3 months*
Participants using Bilevel flow generators
Participants who are or may be pregnant
Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
Participants (or participants bed partners) with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
Single group
Positive Airway Pressure
DeviceThe 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.
This trial is not recruiting at the moment. You can still explore other options:
