ClinicalTrials.gg
Not yet recruitingNCT07785310Updated Aug 27, 2026

PAP-NAP Device Clinical Study

An interventional study of APL Device in Obstructive Sleep Apnea, sponsored by ResMed. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by ResMed · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 50 studies in Sleep Apnea, Obstructive by ResMed — 9 open to participants now, 10 under way, none of them phase 3. Sleep Apnea, Obstructive · ResMed.

Planned enrollment
40th of 42
10 · median 30
Started
2027
the only one that year
No phase
40 of 50
6 open now
Registered
50th of 50
by date

Among the 50 studies in Sleep Apnea, Obstructive by ResMed, this one is the 40th largest by planned enrollment of the 42 interventional ones, is the only one that started in 2027, is one of 40 with no phase, and was the 50th registered.

By phase

50 studies; the count open now beside each. This study's row is marked.

No phasethis study40 · 6 open
Observational7 · 1 open
Other kind1 · 1 open
Phase 21 · 0 open
Phase 41 · 1 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2027.

Size and results

Median enrollment 30 across the 42 interventional studies, 430 across the 8 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 50 studies in Sleep Apnea, Obstructive by ResMed, or all of them as a file.
02

Study 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).

Read the detailed description

This exploratory pilot clinical investigation is designed to evaluate the usability and short-term tolerability of the investigational positive airway pressure (PAP) device during a supervised daytime nap session in adults with obstructive sleep apnea (OSA) who are established continuous positive airway pressure (CPAP) users. The study focuses on early-stage human factors and usability assessment to support iterative device development and future clinical investigation planning.

Approximately 10-15 adult participants with diagnosed OSA who are currently using CPAP therapy will attend a single supervised in-clinic visit in a simulated bedroom environment. Participants will undergo device fitting and instruction before attempting a daytime nap of up to 90 minutes using the investigational device. During the session, trained study personnel will monitor participant safety and device performance through direct and/or remote observation.

The primary evaluation focuses on participant-reported usability outcomes, including comfort, seal, perceived weight, and ease of use. Secondary and exploratory assessments include ability to initiate sleep while using the device, observed sleep-related behaviours, session completion, tolerability, and descriptive sleep-related data collected from a contactless under-mattress monitoring device. Data collected from this study are intended to support design refinement, usability optimisation, and planning of future clinical studies involving wearable PAP technologies.

03

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • OSA
  • CPAP
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to provide written
  • 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 device

Exclusion criteria

Exclusion Criteria:

  • 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., [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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study 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.

    Device: APL Device

Interventions

  • DeviceAPL 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.

06

What researchers measure

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.

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

Secondary outcomes

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

    Number of participants observed by trained study personnel to achieve sleep onset during the supervised daytime PAP-NAP session while using the investigational device, based on predefined observational criteria.

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

  2. Number of Participants Completing the Supervised PAP-NAP Session

    Number of participants who successfully complete the supervised daytime PAP-NAP session while using the investigational APL PAP device.

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

  3. Number of Participants With Early Session Termination Due to Device Intolerance

    Number of participants who prematurely terminate the supervised daytime PAP-NAP session due to device-related intolerance, discomfort, or other tolerability-related issues.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07785310
Lead sponsor
ResMed
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Alisha Middleton, BSc (Sport & Exercise Science)
Contact
alisha.middleton@resmed.com.au
+61422514889
Xueling Zhu
principal investigator · ResMed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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