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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:Alison Wimms, PhD
- 電話番号:0466015420
- メール:alison.wimms@resmed.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Standard MAD pathway
|
A usual-care group receiving standard MAD therapy (Narval CC MAD alone).
|
|
実験的: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Mean overall patient reported experience measure (PREM) questionnaire score
時間枠:1 month
|
1 month
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MA05022026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
閉塞性睡眠時無呼吸(OSA)の臨床試験
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Fujian Shengdi Pharmaceutical Co., Ltd.募集
Narval MRD deviceの臨床試験
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Cancer Institute and Hospital, Chinese Academy...まだ募集していません