Obstructive Sleep Apnea (OSA)Phase 4INFORMNCT07564310
INFORMing Patients With Oximetry Data to Improve MAD Engagement
A Phase 4 study testing Narval MRD device and MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application), in people with Obstructive Sleep Apnea (OSA), run by ResMed.
Trial summary
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk. Mandibular advancement devices (MADs) are a guideline-supported, non-invasive alternative to CPAP for patients with mild to moderate OSA and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Narval MRD device and MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 May 2027
- Phase
- Phase 4
- 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; ≥ 18 years of age; Participants who have mild-to-moderate OSA, or severe OSA where CPAP has failed, is not tolerated, or is refused; Participants who can participate in the study for up to 4 weeks; Participants who own and can use a smartphone that is compatible with the study app; Participants who have the cognitive ability to follow the study instructions and procedures; Participants who have undergone a panoramic X-ray and are deemed suitable for MRD use
Who cannot join
- Participants who are pregnant or may be pregnant; Participants who have a major psychiatric disorder that, in the investigator's opinion, could interfere with participation; Participants who have severe insomnia, for example usually sleeping less than about four hours per night; Participants believed to be unsuitable for the study for safety or other medical reasons by the investigator; Participants who are currently enrolled in another medical clinical study; Participants who have central sleep apnoea; Participants who have severe respiratory disorders other than OSA; Participants who have dental contraindications to using an oral appliance, such as loose teeth or advanced periodontal (gum) disease; Participants who have a completely edentulous lower arch (no lower teeth) unless a complete denture that is mechanically retained (for example, by implants) is present; Participants who have a completely edentulous upper arch (no upper teeth) unless a complete upper denture is present; Participants who have short teeth and/or insufficient undercuts to retain the device securely
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: INFORMing Patients With Oximetry Data to Improve Mandibular Advancment Device (MAD) Engagement
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.
Mandibular advancement devices (MADs) are a guideline-supported, non-invasive alternative to CPAP for patients with mild to moderate OSA and for those with severe OSA who refuse or cannot tolerate CPAP.
Read more
MAD therapy relies heavily on patient engagement and sustained use over time. However, in usual care, patients typically have limited access to objective information about their treatment response. Titration is often based on intermittent assessments and subjective symptom reporting, with little real-time feedback to patients on treatment effectiveness.
This lack of visibility may limit patient understanding of their condition, reduce engagement with therapy, and delay optimisation of treatment.
Advances in nocturnal oximetry now enable multi-night, home-based assessment of oxygen desaturation and related metrics. The myNarval CC solution provides patients, alongside clinicians, with access to objective oximetry data during MAD therapy. By increasing patient awareness of treatment response, this approach has the potential to enhance engagement, support adherence, and improve the overall treatment experience.
The purpose of this study is to evaluate whether access to oximetry data through the myNarval CC solution improves patient-reported experience measures (PREMs) compared with standard care in patients treated with MADs for OSA.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Narval MRD device, MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
- Keywords
- mandibular advancement device MAD
- 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.
Narval MRD deviceDevice
A usual-care group receiving standard MAD therapy (Narval CC MAD alone).
MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),Device
An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Standard MAD pathway | Active comparator | Not described Receives: Device: Narval MRD device |
| myNarval MAD pathway | Experimental | An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application), Receives: Device: MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean overall patient reported experience measure (PREM) questionnaire score
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 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 Apnea (OSA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564310
- Sponsor's protocol ID
- MA05022026
- Acronym
- INFORM
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFORMing Patients With Oximetry Data to Improve Mandibular Advancment Device (MAD) Engagement
- ClinicalTrials.gov ID
- NCT07564310
- Acronym / sponsor ID
- INFORM / MA05022026
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- mandibular advancement device MAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 4 May 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.
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.
Mandibular advancement devices (MADs) are a guideline-supported, non-invasive alternative to CPAP for patients with mild to moderate OSA and for those with severe OSA who refuse or cannot tolerate CPAP.
MAD therapy relies heavily on patient engagement and sustained use over time. However, in usual care, patients typically have limited access to objective information about their treatment response. Titration is often based on intermittent assessments and subjective symptom reporting, with little real-time feedback to patients on treatment effectiveness.
This lack of visibility may limit patient understanding of their condition, reduce engagement with therapy, and delay optimisation of treatment.
Advances in nocturnal oximetry now enable multi-night, home-based assessment of oxygen desaturation and related metrics. The myNarval CC solution provides patients, alongside clinicians, with access to objective oximetry data during MAD therapy. By increasing patient awareness of treatment response, this approach has the potential to enhance engagement, support adherence, and improve the overall treatment experience.
The purpose of this study is to evaluate whether access to oximetry data through the myNarval CC solution improves patient-reported experience measures (PREMs) compared with standard care in patients treated with MADs for OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard MAD pathway | Active comparator | Device: Narval MRD device |
| myNarval MAD pathway | Experimental | Device: MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants willing to give written informed consent; Participants who can read and comprehend English; ≥ 18 years of age; Participants who have mild-to-moderate OSA, or severe OSA where CPAP has failed, is not tolerated, or is refused; Participants who can participate in the study for up to 4 weeks; Participants who own and can use a smartphone that is compatible with the study app; Participants who have the cognitive ability to follow the study instructions and procedures; Participants who have undergone a panoramic X-ray and are deemed suitable for MRD use
Key exclusion criteria (1 listed)
- Participants who are pregnant or may be pregnant; Participants who have a major psychiatric disorder that, in the investigator's opinion, could interfere with participation; Participants who have severe insomnia, for example usually sleeping less than about four hours per night; Participants believed to be unsuitable for the study for safety or other medical reasons by the investigator; Participants who are currently enrolled in another medical clinical study; Participants who have central sleep apnoea; Participants who have severe respiratory disorders other than OSA; Participants who have dental contraindications to using an oral appliance, such as loose teeth or advanced periodontal (gum) disease; Participants who have a completely edentulous lower arch (no lower teeth) unless a complete denture that is mechanically retained (for example, by implants) is present; Participants who have a completely edentulous upper arch (no upper teeth) unless a complete upper denture is present; Participants who have short teeth and/or insufficient undercuts to retain the device securely
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 |
|---|---|---|
| Narval MRD deviceA usual-care group receiving standard MAD therapy (Narval CC MAD alone). | Device | Standard MAD pathway |
| MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application | Device | myNarval MAD pathway |
Primary outcome
Mean overall patient reported experience measure (PREM) questionnaire score
Time frame: 1 month
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 4 May 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 Phase 4 study testing Narval MRD device and MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application), in people with Obstructive Sleep Apnea (OSA), 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 1 inclusion and 1 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 4 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alison Wimms, PhD (0466015420, alison.wimms@resmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean overall patient reported experience measure (PREM) questionnaire score (time frame: 1 month). 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 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.