INFORMing Patients With Oximetry Data to Improve MAD Engagement (INFORM)
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.
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Alison Wimms, PhD
- Telefonnummer: 0466015420
- E-post: alison.wimms@resmed.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard MAD pathway
|
A usual-care group receiving standard MAD therapy (Narval CC MAD alone).
|
|
Experimentell: myNarval MAD pathway
An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application),
|
An intervention group receiving the myNarval solution (Narval CC MAD + O2 ring + MyNarval smartphone application
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Mean overall patient reported experience measure (PREM) questionnaire score
Tidsram: 1 month
|
1 month
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MA05022026
Plan för individuella deltagardata (IPD)
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