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NOT YET RECRUITING
NCT07564310
PHASE4

INFORMing Patients With Oximetry Data to Improve MAD Engagement

Sponsor: ResMed

View on ClinicalTrials.gov

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 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.

Official title: INFORMing Patients With Oximetry Data to Improve Mandibular Advancment Device (MAD) Engagement

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-01

Completion Date

2027-05-01

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DEVICE

Narval MRD device

A usual-care group receiving standard MAD therapy (Narval CC MAD alone).

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