PAP-NAP Device Clinical Study

NCT07785310 | Not Yet Recruiting

• 1 other identifier: SLP-26-04-02
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment. The study is designed to assess participant experience with the investigational PAP device, including comfort, fit and seal, ease of use, and ability to fall asleep while using the device. Participants will attend a supervised PAP-Nap session where they will use the PAP device while resting or attempting to sleep. Study staff will also observe sleep-related behaviours, including sleep onset and session completion. Information collected from this study will help inform future development and refinement of wearable PAP technologies intended for the treatment of obstructive sleep apnea (OSA).

Conditions

Obstructive Sleep Apnea

Keywords

OSA; CPAP

Outcome Measures

Primary Outcomes (1)

• Feasibility and Usability of the Investigational PAP Device During a Supervised Daytime PAP-NAP Session

  Participant-reported feasibility and usability of the investigational APL PAP device during a supervised daytime PAP-NAP session, assessed using an 11-point Likert scale (0-10) across predefined device-related domains including comfort, mask seal, stability, and ease of use/application.

  Immediately following the supervised daytime nap session (single study visit; up to 3 hours)

Secondary Outcomes (3)

• Number of Participants Achieving Observed Sleep Onset During the Supervised PAP-NAP Session

  During the supervised daytime PAP-NAP session (up to 90 minutes)

• Number of Participants Completing the Supervised PAP-NAP Session

  During and immediately following the supervised daytime nap session (up to 90 minutes)

• Number of Participants With Early Session Termination Due to Device Intolerance

  During the supervised daytime PAP-NAP session (up to 90 minutes)

Study Arms (1)

APL Wearable PAP Device

EXPERIMENTAL

Participants with obstructive sleep apnea (OSA) currently using CPAP therapy will use the investigational positive airway pressure (PAP) device during a supervised daytime nap session in a simulated bedroom environment. The study will assess device usability, comfort, seal, ease of use, tolerability, and ability to initiate sleep during short-term use.

Device: APL Device

Interventions

APL Device DEVICE

The investigational intervention is a prototype novel positive airway pressure (PAP) device for the treatment of obstructive sleep apnea (OSA). Participants will use the device during a supervised daytime nap session in a simulated bedroom environment to evaluate usability and short-term tolerability, including comfort, seal, ease of use, and ability to initiate sleep.

APL Wearable PAP Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Able to read and comprehend English
• Aged 18 years or older
• Currently using continuous positive airway pressure (CPAP) therapy for at least 3 months for treatment of obstructive sleep apnea (OSA)
• Using CPAP mode with a fixed therapeutic pressure less than 16 cmH2O
• Current user of a nasal mask interface and appropriately fitted to a medium-sized nasal mask
• Agree to supervised monitoring, including video observation, during the nap session
• Willing and able to attend a single in-clinic visit and attempt a supervised daytime nap of up to 90 minutes using the investigational device

You may not qualify if:

• Current use of bilevel positive airway pressure devices
• Pregnant or possibly pregnant
• Pre-existing lung disease or condition that may predispose to pneumothorax (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, pulmonary fibrosis, recent pneumonia or lung infection within the past 2 years, or lung injury)
• Active implanted medical devices that may interact with magnets, including pacemakers, implantable cardioverter defibrillators (ICDs), neurostimulators, cerebrospinal fluid shunts, or infusion pumps
• Any condition or circumstance that, in the opinion of the investigator, could make participation unsafe or interfere with interpretation of study results
• Currently enrolled in another clinical study

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; alisha.middleton@resmed.com.au

Study Design

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

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share