Obstructive Sleep ApneaNCT06769607
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
A study testing Investigational algorithm in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial summary
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea. 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?
- Investigational algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Apr 2025to Dec 2025
- 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
- Participants willing to give written informed consent.
- Participants who can read and comprehend English.
- Participants who ≥ 18 years of age
- Participants who have been using a ResMed AirSense 10 or 11 device.
- Participants currently using AutoSet (APAP) mode.
- Participants being established on PAP therapy for the treatment of OSA for approximately >3 months.
- Participants who can participate in the study for up to 8 weeks.
Who cannot join
- Participants using Bilevel flow generators.
- Participants using CPAP, AutoSet for Her
- 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 are currently enrolled in other medical clinical studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
ResMed Ltd
Bella Vista, New South Wales, 2153
Sumudu Herath, +61 288841722, sumudu.herath@resmed.com.au
About this study
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
Read the detailed description
This is a blind, randomized cross over (or single arm depending on phase) study aiming to show that the new algorithm is efficacious in the treatment of obstructive sleep apnea (OSA). Furthermore, it allows for the comparison of relevant objective data parameters from the device and subjective outcomes in comparison to an established algorithm.
This study is planned in two phases. Phase 1 aims to gain confidence that the algorithm is functioning as intended, and allow for minor modifications to be made to the software before proceeding to Phase 2.
Phase 2 aims to assess the performance of the algorithm in a broader range of participants to capture data and subjective feedback comparing the users experience between the new algorithm and the control algorithm.
After the conclusion of phase 1 and 2, an optional extended trial period will be offered to participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
The study will be conducted in the home environment. Participants who met the inclusion/exclusion criteria will be contacted. 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. In addition, subjects may be asked if they are willing to wear a wearable during both day and night (unless charging) for the duration of the study iteration. The wearable will be a commercially available wellness wearable that collects data to provide information about sleep and activity.
Visit 1 Participants will provide written informed consent. Participants will be set up on the algorithm they are first randomized to. If the participant and assessor are happy to proceed, the participants will take the device home to trial the first randomized algorithm, participants will be asked to complete a questionnaire regarding their therapy experience.
Visit 2 Participants will then be switched to the alternative algorithm and take the study device home to test. After trialling the second algorithm, participants will be asked to complete a questionnaire regarding their therapy experience and overall preferences.
Note: Visit 2 is not required if a cross over is not required in Phase 1.
Visit 3 The participant will return the investigational device to the assessor. The participants' questionnaire responses will be reviewed. Participants will be reimbursed. This concludes the participation in the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Investigational algorithm, Control algorithm
- 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.
Investigational algorithmDevice
Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.
Control algorithmDevice
Released algorithm intended for the treament of Obstructive Sleep Apnea
| Study group | Role | What they receive |
|---|---|---|
| Investigational algorithm | Experimental | The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings. Receives: Device: Investigational algorithm |
| Control algorithm | Active comparator | The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings. Receives: Device: Control algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the algorithm efficacy (AHI) to a clinically relevant data
The mean residual AHI of the investigational algorithm will be compared against an excepted clinical benchmark of 5 using a one sample t test.
Measured: 8 weeks
Secondary outcomes (6)
Secondary endpoint: Device usage
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm.
Objective statistics on "Device usage" in hours per day (Hrs) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Measured: From enrolment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Leak
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm.
Objective statistics on "Leak" in litres per minute (L/min) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Measured: From enrollment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Pressure
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm.
Objective statistics on "Pressure" in centimeters of water (cmH2O) stored in the PAP device will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Measured: From enrolment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Subjective scores
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm and/or Criterion score of 6.
Subjective scores will be collected from participants on each item (e.g. comfort, breathign comfort, ease of falling asleep). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable whereas score of 0 is considered very unfavorable.
Measured: From enrolment to the end of each study arm (up to 8 weeks)
Wearable data - Sleep metrics
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm. Objective statistics on sleep metrics measured via the wearable will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Measured: From enrolment to the end of each study arm (up to 8 weeks)
Wearable data - Activity Metrics
Hypothesis: the investigational algorithm will be equivalent or better than the comparison algorithm. Objective statistics on activity metrics measured via the wearable will be downloaded. These parameters will be captured from each arm of testing and results will be analysed and compared.
Measured: From enrolment to the end of each study arm (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start10 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- This is a blind, randomized cross over (or single arm) study aiming to show that the new algorithm is efficacious in the treatment of OSA. Furthermore, it allows for the comparison of relevant objective data parameters from the device, wearable data and subjective outcomes in comparison to an established algorithm. The study is planned in two phases. Phases may be repeated until sufficient confidence is gained of the intended behavior of the investigational algorithm and to ensure that the sample has appropriate coverage of different user experiences which can impact study outcomes (e.g. comfort settings such as soft response). After the conclusion of phase 1 and 2, participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769607
- Sponsor's protocol ID
- SLP-24-10-01
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2024
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
- ClinicalTrials.gov ID
- NCT06769607
- Acronym / sponsor ID
- SLP-24-10-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jan 2025 (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 study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
Detailed description
This is a blind, randomized cross over (or single arm depending on phase) study aiming to show that the new algorithm is efficacious in the treatment of obstructive sleep apnea (OSA). Furthermore, it allows for the comparison of relevant objective data parameters from the device and subjective outcomes in comparison to an established algorithm.
This study is planned in two phases. Phase 1 aims to gain confidence that the algorithm is functioning as intended, and allow for minor modifications to be made to the software before proceeding to Phase 2.
Phase 2 aims to assess the performance of the algorithm in a broader range of participants to capture data and subjective feedback comparing the users experience between the new algorithm and the control algorithm.
After the conclusion of phase 1 and 2, an optional extended trial period will be offered to participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
The study will be conducted in the home environment. Participants who met the inclusion/exclusion criteria will be contacted. 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. In addition, subjects may be asked if they are willing to wear a wearable during both day and night (unless charging) for the duration of the study iteration. The wearable will be a commercially available wellness wearable that collects data to provide information about sleep and activity.
Visit 1 Participants will provide written informed consent. Participants will be set up on the algorithm they are first randomized to. If the participant and assessor are happy to proceed, the participants will take the device home to trial the first randomized algorithm, participants will be asked to complete a questionnaire regarding their therapy experience.
Visit 2 Participants will then be switched to the alternative algorithm and take the study device home to test. After trialling the second algorithm, participants will be asked to complete a questionnaire regarding their therapy experience and overall preferences.
Note: Visit 2 is not required if a cross over is not required in Phase 1.
Visit 3 The participant will return the investigational device to the assessor. The participants' questionnaire responses will be reviewed. Participants will be reimbursed. 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
- This is a blind, randomized cross over (or single arm) study aiming to show that the new algorithm is efficacious in the treatment of OSA. Furthermore, it allows for the comparison of relevant objective data parameters from the device, wearable data and subjective outcomes in comparison to an established algorithm. The study is planned in two phases. Phases may be repeated until sufficient confidence is gained of the intended behavior of the investigational algorithm and to ensure that the sample has appropriate coverage of different user experiences which can impact study outcomes (e.g. comfort settings such as soft response). After the conclusion of phase 1 and 2, participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
| Arm | Type | Receives |
|---|---|---|
| Investigational algorithm | Experimental | Device: Investigational algorithmThe participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings. |
| Control algorithm | Active comparator | Device: Control algorithmThe participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants willing to give written informed consent.
- Participants who can read and comprehend English.
- Participants who ≥ 18 years of age
- Participants who have been using a ResMed AirSense 10 or 11 device.
- Participants currently using AutoSet (APAP) mode.
Key exclusion criteria (6 listed)
- Participants using Bilevel flow generators.
- Participants using CPAP, AutoSet for Her
- 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.
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 |
|---|---|---|
| Investigational algorithmInvestigational algorithm developed for the treatment of Obstructive Sleep Apnea. | Device | Investigational algorithm |
| Control algorithmReleased algorithm intended for the treament of Obstructive Sleep Apnea | Device | Control algorithm |
Primary outcome
Comparison of the algorithm efficacy (AHI) to a clinically relevant data
Time frame: 8 weeks
The mean residual AHI of the investigational algorithm will be compared against an excepted clinical benchmark of 5 using a one sample t test.
6 secondary outcomes
Secondary endpoint: Device usage
Time frame: From enrolment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Leak
Time frame: From enrollment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Pressure
Time frame: From enrolment to the end of each study arm (up to 8 weeks)
Secondary endpoint: Subjective scores
Time frame: From enrolment to the end of each study arm (up to 8 weeks)
Wearable data - Sleep metrics
Time frame: From enrolment to the end of each study arm (up to 8 weeks)
Wearable data - Activity Metrics
Time frame: From enrolment to the end of each study arm (up to 8 weeks)
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 2 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational algorithm in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sumudu Herath (+61 288841722, sumudu.herath@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the algorithm efficacy (AHI) to a clinically relevant data (time frame: 8 weeks). 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 2 Dec 2025.