Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnea.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Subjective usability and overnight acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
APL Mask system tethered overnight study
Participants will use APL mask system with a released PAP device for the treatment of OSA.
干预措施: Positive Airway Pressure (Device)
结局指标
主要结局
Subjective usability and overnight acceptability
时间窗: 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.
次要结局
未报告次要终点