DISE vs Muller's Maneuver in OSA Assessment
Role of Drug-Induced Sleep Endoscopy in Comparison to Muller's Maneuver in Obstructive Sleep Apnea Syndrome Assessment
調査の概要
詳細な説明
Obstructive sleep apnea (OSA) is one of the most common sleep-related breathing disorders and is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, leading to intermittent hypoxia, sleep fragmentation, and significant cardiovascular and metabolic consequences. Accurate localization of the site and pattern of upper airway collapse is essential for selecting the most appropriate treatment strategy.
Müller's maneuver is a commonly used office-based endoscopic technique that evaluates upper airway collapse during forced inspiratory effort while the patient is awake. However, its diagnostic accuracy has been questioned because it does not replicate the physiological conditions of natural sleep. Drug-Induced Sleep Endoscopy (DISE) is a dynamic endoscopic examination performed under sedation, allowing direct visualization of the upper airway during a sleep-like state and providing detailed information regarding the level, degree, and configuration of airway collapse.
The present prospective study aims to compare the findings of Drug-Induced Sleep Endoscopy with those obtained by Müller's maneuver in patients diagnosed with obstructive sleep apnea. The study will evaluate the agreement between both techniques in identifying the site and pattern of upper airway obstruction and assess the potential additional diagnostic value of DISE in the preoperative assessment and treatment planning of patients with OSA. The findings of this study may help optimize patient selection for individualized therapeutic interventions and improve clinical decision-making in the management of obstructive sleep apnea.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Dakahlia Governorate
-
Al Mansurah、Dakahlia Governorate、エジプト、35511
- Mansoua University Hospital
-
-
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:
- Age > 18 years old.
- Diagnosed as OSAS according to polysomnography and AASM (June 2023).
- Body mass index < 40
Exclusion Criteria:
- Age < 18 years.
- Central sleep apnea.
- Hypoventilation syndromes.
- Cardiac arrhythmias.
- ischemic heart disease.
- Heart failure.
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:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
実験的:Single Study Arm
Participants with obstructive sleep apnea will undergo awake flexible endoscopy with Müller's maneuver followed by Drug-Induced Sleep Endoscopy (DISE).
The findings of both procedures will be compared to assess the site, degree, and pattern of upper airway obstruction.
|
Drug-induced sleep endoscopy performed under sedation to evaluate the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Agreement between Drug-Induced Sleep Endoscopy (DISE) using the VOTE cassification and Müller's Maneuver in assesment of OSA.
時間枠:Baseline (during the same study visit)
|
Agreement between Drug-Induced Sleep Endoscopy (DISE) findings, assessed using the VOTE classification, and Müller's maneuver findings in identifying the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
Agreement will be quantified using Cohen's kappa coefficient.
|
Baseline (during the same study visit)
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Lucy Soliman, Professor、Chest Medicine Department, Faculty of Medicine, Mansoura University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。