Obstructive Sleep ApneaNCT06562205
PAP Systems External Clinical Studies (ECS)
A study testing PAP System A (with Amalfi) then PAP System B (with CLA11) and PAP System B (with CLA11) then PAP System A (with Amalfi) in people with Obstructive Sleep Apnea, run by ResMed.
Trial summary
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems. Read more about this study
- Who is it for?
- Ages 18 to 130 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- PAP System A (with Amalfi) then PAP System B (with CLA11) and PAP System B (with CLA11) then PAP System A (with Amalfi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2028to 29 Oct 2028
- 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 to 130 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 3 months
- Participants currently using a suitable PAP system(s)
- Participants who can trial the PAP systems for up to 7 nights each
- Additional criteria for remote studies:
- Participants currently using PAP device compatible with AirView, or with download capacity from PAP machine from data cards
- Participants who have access to video call equipment
Who cannot join
- 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 believed to be unsuitable for inclusion by the researcher
- Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
- Participants who are currently enrolled in other clinical studies
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: External Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
Read the detailed description
This is an open label, prospective, randomized cross over (or single arm) study for ongoing product development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies phases, each of which will have their own sub-protocol outlining the exact specifics of the study.
The studies could be run face-to-face or remotely.
Participants who met the inclusion/exclusion criteria will be contacted. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.
Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.
Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.
Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- 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.
PAP System A (with Amalfi) then PAP System B (with CLA11)Device
PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
PAP System B (with CLA11) then PAP System A (with Amalfi)Device
PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| PAP System A (with Amalfi) then PAP System B (with CLA11) | Experimental | Participants will be asked to take home the investigational PAP system (Amalfi) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System A and PAP System B. This arm will first use the Amalfi for 7 days and then use the CLA 11 for 7 days. Receives: Device: PAP System A (with Amalfi) then PAP System B (with CLA11); Device: PAP System B (with CLA11) then PAP System A (with Amalfi) |
| PAP System B (with CLA11) then PAP System A (with Amalfi) | Active comparator | Participants will be asked to take home the comparator PAP system B (CLA 11) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System B and PAP System A. This arm will first use the CLA 11 for 7 days and then use the Amalfi for 7 days. Receives: Device: PAP System A (with Amalfi) then PAP System B (with CLA11); Device: PAP System B (with CLA11) then PAP System A (with Amalfi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6
Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or Criterion Score of 6
Subjective usability scores will be collected from participants on each usability item (e.g., comfort, seal, ease of use). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable
Measured: 6 weeks
(efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data
Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or clinically relevant data
Objective data stored in the CPAP device will be downloaded wirelessly using a computer program (AirView or ResScan, ResMed). An Apnea hypopnea index (AHI) automatically analyzed by the program will be used. Typically, an AHI <5 demonstrates efficacious treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Aug 2028 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion29 Oct 2028 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- his is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562205
- Sponsor's protocol ID
- SLP-24-08-01
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing
- ClinicalTrials.gov ID
- NCT06562205
- Acronym / sponsor ID
- SLP-24-08-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2028 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 29 Oct 2028 (estimated)
- First posted
- 20 Aug 2024 (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 is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
Detailed description
This is an open label, prospective, randomized cross over (or single arm) study for ongoing product development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies phases, each of which will have their own sub-protocol outlining the exact specifics of the study.
The studies could be run face-to-face or remotely.
Participants who met the inclusion/exclusion criteria will be contacted. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.
Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.
Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.
Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- his is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices.
| Arm | Type | Receives |
|---|---|---|
| PAP System A (with Amalfi) then PAP System B (with CLA11) | Experimental | Device: PAP System A (with Amalfi) then PAP System B (with CLA11), Device: PAP System B (with CLA11) then PAP System A (with Amalfi)Participants will be asked to take home the investigational PAP system (Amalfi) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System A and PAP System B. This arm will first use the Amalfi for 7 days and then use the CLA 11 for 7 days. |
| PAP System B (with CLA11) then PAP System A (with Amalfi) | Active comparator | Device: PAP System A (with Amalfi) then PAP System B (with CLA11), Device: PAP System B (with CLA11) then PAP System A (with Amalfi)Participants will be asked to take home the comparator PAP system B (CLA 11) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System B and PAP System A. This arm will first use the CLA 11 for 7 days and then use the Amalfi for 7 days. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 3 months
- Participants currently using a suitable PAP system(s)
- Participants who can trial the PAP systems for up to 7 nights each
Key exclusion criteria (6 listed)
- 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 believed to be unsuitable for inclusion by the researcher
- Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
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 |
|---|---|---|
| PAP System A (with Amalfi) then PAP System B (with CLA11)PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days | Device | PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi) |
| PAP System B (with CLA11) then PAP System A (with Amalfi)PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days | Device | PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi) |
Primary outcome
(usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6
Time frame: 6 weeks
Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or Criterion Score of 6 Subjective usability scores will be collected from participants on each usability item (e.g., comfort, seal, ease of use). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable
(efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data
Time frame: 6 weeks
Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or clinically relevant data Objective data stored in the CPAP device will be downloaded wirelessly using a computer program (AirView or ResScan, ResMed). An Apnea hypopnea index (AHI) automatically analyzed by the program will be used. Typically, an AHI <5 demonstrates efficacious treatment.
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 24 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing PAP System A (with Amalfi) then PAP System B (with CLA11) and PAP System B (with CLA11) then PAP System A (with Amalfi) 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 24 Apr 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 Xueling Zhu Manager - Clinical Data and Operations (+61288842367, xueling.zhu@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6 (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 24 Apr 2026.