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

NCT07420140 | Not Yet Recruiting DMC

• 1 other identifier: SLP-26-01-02
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

OSA - Obstructive Sleep Apnea

Keywords

OSA; CPAP

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

APL Mask system tethered overnight study

EXPERIMENTAL

Participants will use APL mask system with a released PAP device for the treatment of OSA.

Device: Positive Airway Pressure

Interventions

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.

APL Mask system tethered overnight study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Xueling Zhu

  ResMed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha Middleton, BSc (Sport & Exercise Science)

CONTACT

+61422514889; middleton.alisha@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share