PAP-NAP Device Clinical Study

Sponsor
ResMed
Study ID
NCT07785310
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

First listed
Aug 25, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: APL Wearable PAP Device
    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.

Primary Outcome Measure

Feasibility and Usability of the Investigational PAP Device During a Supervised Daytime PAP-NAP Session [ Time Frame: Immediately following the supervised daytime nap session (single study visit; up to 3 hours) ]

Central Contacts

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