Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive Airway Pressure.
- Who it may be relevant to
- Registry conditions: OSA - Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnea.
Overview
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
- Device Positive 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.
Primary outcome measures
- Subjective usability and overnight acceptability [Time frame: 7 nights]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07420140 · SLP-26-01-02