Pathophysiology of the Upper Airway in Patients With COPD and Concomitant OSA
Pathophysiology of the Upper Airway in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Concomitant Obstructive Sleep Apnea (OSA)
The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural changes associated with COPD and upper airway inflammation on upper airway collapsibility. Upper airway collapsibility is closely associated with development of obstructive sleep apnea (OSA), which is a common disease characterized by repetitive collapse of upper airway during sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular consequences, especially in patients with COPD.
Participants in this research study will undergo two overnight sleep studies (PSGs), pulmonary function test, and CT scan of the upper airway and chest. The first sleep study will evaluate the sleep breathing disorder and the second sleep study will measure the upper airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a modified continuous positive airway pressure (CPAP) machine which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure.
調査の概要
詳細な説明
This is a physiologic study to assess the effects of lower airway and lung tissue changes of COPD on upper airway collapsibility. Increased in lung volume and destruction of alveolar wall in COPD may have opposite and various effects on the upper airway collapsibility, which is an important factor of OSA development.
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are very common disorders associated with considerable morbidity, mortality, and healthcare costs. The prevalence of both co-existing conditions is estimated to be ~4% of the general population. This COPD-OSA "overlap" syndrome causes more severe hypoxemia than either COPD or OSA alone and has important clinical consequences, including death. COPD is usually excluded in OSA research and OSA is typically excluded or not assessed in studies of COPD; thus, available information about the "overlap" syndrome is limited. Therefore, it is important to identify patients with both COPD and OSA and determine the mechanisms of poor outcomes for these patients in order to optimize therapy. The pathophysiology of the COPD-OSA syndrome is not well understood. The investigators propose to investigate upper airway (UA) anatomic characteristics and collapsibility as potential underlying mechanisms that may help to explain the negative additive effect of having both conditions. The objectives are to study CT measures of airway anatomy and the critical closing pressure of the upper airway (Pcrit), a gold standard measure of upper airway collapsibility, in patients with COPD-OSA compared with COPD only and normal controls. CT scan of upper airway and chest will allow precise measures of upper airway characteristics and COPD associated alveolar and lower airway ch. angesMeasures of upper airway collapsibility will provide us information about the mechanical nature of the airway and if the patients are more likely to have OSA. Subjects with COPD-OSA may exhibit more upper airway inflammation possibly due to their pre-existing COPD disease and the reoccurring opening and closing of the upper airway due to the OSA. Therefore the investigators would like to assess the degree of inflammation in these patients compared to normal controls.
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
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California
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San Diego、California、アメリカ、92093
- University of California, San Diego
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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
説明
Inclusion Criteria for COPD Subjects:
- Age range 40-70 years.
- Demonstrated moderate to severe COPD as determined by spirometry (post-bronchodilator spirometry FEV1/FVC < 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
- Smoking history of ≥ 10 pack-years
Inclusion Criteria for Control Subjects
- Age range 40-70 years
- Demonstrated no COPD as determined by normal spirometry (post-bronchodilator spirometry FEV1/FVC > 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
- No smoking history as defined by less than 100 cigarettes smoked in a lifetime
Exclusion Criteria for both COPD and Control Subjects:
- Metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis
Subjects unable to perform spirometry due to:
- chest or abdominal surgery in the past three months
- a heart attack in the last three months
- detached retina or eye surgery in the past three months
- hospitalization for any other heart problem in the past month
- History of hypersensitivity to Afrin, Lidocaine or albuterol
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day
- Pregnancy or suspected pregnancy
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：非ランダム化
- 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 |
|---|---|
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アクティブコンパレータ：COPD Group
Patients who were previously diagnosed of moderate to severe COPD as determined by spirometry.
All patients will have sleep and pulmonary physiologic measurements.
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Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
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アクティブコンパレータ：Normal Control Group
Patients who are healthy, without major medical or sleep problems, and have normal spirometry.
All patients will have sleep and pulmonary physiologic measurements.
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Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
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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 |
|---|---|---|
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Critical closing pressure (PCrit)
時間枠：Baseline
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Measured during overnight sleep study
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Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pharyngeal lavage cell count distribution
時間枠：Baseline
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Baseline
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Minimal later airway dimension (mLAT)
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Minimal anteroposterior airway dimension (mAP)
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Minimal cross sectional airway area (mCSA)
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Lateral airway dimension on hard palate/uvula/epiglottis level
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Anteroposterior airway dimension on hard palate/uvula/epiglottis level
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Cross-sectional airway area on hard palate/uvula/epiglottis level
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Distance between the lower edge of the mandible and the lower edge of the hyoid (MH)
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Upper airway length
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Width of hard palate
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Nasophayngeal/retropalatal/retroglossal pharyngeal cavity volume
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Volume within the cervico-mandibular bony frame
時間枠：Baseline
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Measured from upper airway CT scan
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Baseline
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Volume of retropalatal/retroglossal soft tissue
時間枠：Baseline
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Baseline
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Parapharyngeal fat pad volume
時間枠：Baseline
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Baseline
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Tongue volume
時間枠：Baseline
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Baseline
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Emphysema score
時間枠：Baseline
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Measured from CT chest scan
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Baseline
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Emphysema distribution
時間枠：Baseline
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Measured from CT chest scan
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Baseline
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Lower airway wall thickness on chest CT scan
時間枠：Baseline
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Measured from CT chest scan
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Baseline
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Forced expiratory volume in 1 second (FEV1)
時間枠：Baseline
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Baseline
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Total lung capacity (TLC)
時間枠：Baseline
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Baseline
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Ratio of residual volume / total lung capacity (RV/TLC)
時間枠：Baseline
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Baseline
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Diffusing capacity of the lung for carbon monoxide (DLCO)
時間枠：Baseline
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Baseline
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協力者と研究者
捜査官
- 主任研究者：Xavier Soler, MD, PhD、University of California, San Diego
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 (見積もり)
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。
閉塞性睡眠時無呼吸の臨床試験
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Fujian Shengdi Pharmaceutical Co., Ltd.募集
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症（くも膜下出血）ドイツ