NCT07420140

Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.

Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnea.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• OSA - Obstructive Sleep Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-02-19
• Last updated: 2026-02-19