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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APL Mask system tethered overnight study | Experimental | Participants will use APL mask system with a released PAP device for the treatment of OSA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 nights |
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Inclusion Criteria: • Participants willing to give written informed consent
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 on APAP therapy*
Participants currently using a Resmed AirFit N20 Medium mask*
Participants who are employees of Resmed^
Exclusion Criteria:
Participants using Bilevel flow generators
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alisha Middleton, BSc (Sport & Exercise Science) | Contact | +61422514889 | middleton.alisha@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xueling Zhu | ResMed | Principal Investigator |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |