INFORMing Patients With Oximetry Data to Improve MAD Engagement

NCT07564310 | Not Yet Recruiting Phase 4

• 1 other identifier: MA05022026
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

mandibular advancement device MAD

Outcome Measures

Primary Outcomes (1)

• Mean overall patient reported experience measure (PREM) questionnaire score

  1 month

Study Arms (2)

Standard MAD pathway

ACTIVE COMPARATOR

Device: Narval MRD device

myNarval MAD pathway

EXPERIMENTAL

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),

Interventions

Narval MRD device DEVICE

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

Standard MAD pathway

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

myNarval MAD pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Alison Wimms, PhD

CONTACT

0466015420; alison.wimms@resmed.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share