OSA - Obstructive Sleep Apnea
Conditions
Keywords
OSA, CPAP
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPositive Airway Pressure
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.
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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\^ * Only applicable to participants with OSA \^ Only applicable to internal participants
Exclusion criteria
* 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). * Participants (or participants bed partners) with metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye) * Participants who are currently enrolled in other clinical studies * Participants believed to be unsuitable\* for inclusion by the researcherꝉ
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective usability and overnight acceptability | 7 nights | 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. |
Contacts
CONTACTAlisha Middleton, BSc (Sport & Exercise Science)
PRINCIPAL_INVESTIGATORXueling Zhu
ResMed
Outcome results
None listed