Obstructive Sleep ApneaNCT07785310
PAP-NAP Device Clinical Study
A study testing APL Device in people with Obstructive Sleep Apnea, run by ResMed.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- APL Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Feasibility, Usability and Short-Term Tolerability of a Prototype Positive Airway Pressure (PAP) Device During a Supervised Daytime Nap
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- APL Device
- Keywords
- OSA, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: APL Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: During the supervised daytime PAP-NAP session (up to 90 minutes)
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.
Measured: During and immediately following the supervised daytime nap session (up to 90 minutes)
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.
Measured: During the supervised daytime PAP-NAP session (up to 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xueling Zhu, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785310
- Sponsor's protocol ID
- SLP-26-04-02
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility, Usability and Short-Term Tolerability of a Prototype Positive Airway Pressure (PAP) Device During a Supervised Daytime Nap
- ClinicalTrials.gov ID
- NCT07785310
- Acronym / sponsor ID
- SLP-26-04-02
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, CPAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APL Wearable PAP Device | Experimental | Device: APL DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL DeviceThe 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. | Device | APL Wearable PAP Device |
Primary outcome
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)
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.
3 secondary outcomes
Number of Participants Achieving Observed Sleep Onset During the Supervised PAP-NAP Session
Time frame: During the supervised daytime PAP-NAP session (up to 90 minutes)
Number of Participants Completing the Supervised PAP-NAP Session
Time frame: During and immediately following the supervised daytime nap session (up to 90 minutes)
Number of Participants With Early Session Termination Due to Device Intolerance
Time frame: During the supervised daytime PAP-NAP session (up to 90 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueling Zhu principal investigator
ResMed
Questions about this trial
What is this clinical trial studying?
A study testing APL Device in people with Obstructive Sleep Apnea, run by ResMed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha Middleton, BSc (Sport & Exercise Science) (+61422514889, alisha.middleton@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.