A Phase 4 interventional study of Narval MRD device and MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application), in Obstructive Sleep Apnea (OSA), sponsored by ResMed. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by ResMed · Phase 4, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Narval MRD device
An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application),
Device: MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
A usual-care group receiving standard MAD therapy (Narval CC MAD alone).
An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application
Mean overall patient reported experience measure (PREM) questionnaire score
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.
Of 31 phase 4 interventional studies under Sleep Apnea, Obstructive, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 35. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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