Diaphragmatic Ultrasound and Hypoxic Burden in "Osa" (osa)
Diaphragmatic Ultrasound and Muscle Reserve in Obstructive Sleep Apnea Syndrome: Association With Nocturnal Hypoxic Burden and Polysomnographic Parameters
-
Primary objective To investigate the association between diaphragmatic ultrasound-derived indices, particularly diaphragmatic reserve, and hypoxic burden in patients with OSA.
-
Secondary objectives:
- To characterize diaphragmatic thickness, thickening fraction, and excursion in patients with OSA.
- To determine the relationship between diaphragmatic ultrasound parameters and polysomnographic parameters as: AHI, ODI, T90, mean SpO₂, minimum SpO₂, REM-AHI, supine AHI, arousal index.
調査の概要
状態
条件
詳細な説明
Obstructive sleep apnea (OSA) is a serious health condition that has been estimated to affect nearly 936 million adults aged between 30 and 69 worldwide according to recent to recent global estimates.
OSA is therefore a very common condition that results in several health consequences, such as cardiovascular pathology, metabolic disruptions, cognitive decline .
attended Polysomnography (PSG) is considered the gold standard for diagnosis of OSA ,with apnea-hypopnea index (AHI) as the more frequently used indicator of disease severity.
However in recent studies AHI have been shown to be inconsistently related to adverse consequences of OSA Hypoxic burden defined as the sum of individual area under oxygen saturation curves related to every respiratory event obtained by pulse oximeter during the total sleep time, has been suggested as a more accurate measure of OSA severity relating to symptoms and adverse effects.
The diaphragm as the most important muscle of respiration, can impact OSA severity although the extent of such effect is still unclear.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Abdulrahman Galal Salih, masters degree
- 電話番号：00201111532712
- メール：abdogalal231295@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
adult patients who are confirmed to have OSA by polysomnography
説明
Inclusion Criteria:
- Aged > 18 years.
- Newly diagnosed OSA using PSG and meeting AASM diagnostic criteria.
- Treatment-naïve with respect to CPAP or other positive-airway-pressure therapy.
- Provide informed consent.
Exclusion Criteria:
-
Respiratory diseases:
Bronchial asthma, COPD, bronchiectasis, interstitial lung disease, neuromuscular respiratory disease
-
Neurological/diaphragmatic disorders:
Neuromuscular disorders, muscular dystrophies, previous major thoracic surgery affecting the diaphragm
-
Other conditions:
decompensated heart failure, significant pulmonary hypertension, active malignancy acute respiratory infection
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
- 観測モデル：CASE_ONLY
- 時間の展望：CROSS_SECTIONAL
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 |
|---|---|
|
Establish a correlation between OSA severity and degree of diaphragmatic dysfunction using hypoxic burden related to diaphragmatic ultrasound parameters
時間枠：Baseline
|
Baseline
|
|
the association between hypoxic burden and diaphragmatic thickness fraction after adjusted for AHI and BMI
時間枠：Baseline
|
Baseline
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Bordoni B, Escher AR, Toccafondi A, Mapelli L, Banfi P. Obstructive Sleep Apnea and Role of the Diaphragm. Cureus. 2022 Sep 10;14(9):e29004. doi: 10.7759/cureus.29004. eCollection 2022 Sep.
- Rundo JV. Obstructive sleep apnea basics. Cleve Clin J Med. 2019 Sep;86(9 Suppl 1):2-9. doi: 10.3949/ccjm.86.s1.02.
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
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。