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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
California
-
San Diego, California, Соединенные Штаты, 92093
- University of California, San Diego
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
|
|
Активный компаратор: 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.
|
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Critical closing pressure (PCrit)
Временное ограничение: Baseline
|
Measured during overnight sleep study
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pharyngeal lavage cell count distribution
Временное ограничение: Baseline
|
Baseline
|
|
|
Minimal later airway dimension (mLAT)
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Minimal anteroposterior airway dimension (mAP)
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Minimal cross sectional airway area (mCSA)
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Lateral airway dimension on hard palate/uvula/epiglottis level
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Anteroposterior airway dimension on hard palate/uvula/epiglottis level
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Cross-sectional airway area on hard palate/uvula/epiglottis level
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Distance between the lower edge of the mandible and the lower edge of the hyoid (MH)
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Upper airway length
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Width of hard palate
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Nasophayngeal/retropalatal/retroglossal pharyngeal cavity volume
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Volume within the cervico-mandibular bony frame
Временное ограничение: Baseline
|
Measured from upper airway CT scan
|
Baseline
|
|
Volume of retropalatal/retroglossal soft tissue
Временное ограничение: Baseline
|
Baseline
|
|
|
Parapharyngeal fat pad volume
Временное ограничение: Baseline
|
Baseline
|
|
|
Tongue volume
Временное ограничение: Baseline
|
Baseline
|
|
|
Emphysema score
Временное ограничение: Baseline
|
Measured from CT chest scan
|
Baseline
|
|
Emphysema distribution
Временное ограничение: Baseline
|
Measured from CT chest scan
|
Baseline
|
|
Lower airway wall thickness on chest CT scan
Временное ограничение: Baseline
|
Measured from CT chest scan
|
Baseline
|
|
Forced expiratory volume in 1 second (FEV1)
Временное ограничение: Baseline
|
Baseline
|
|
|
Total lung capacity (TLC)
Временное ограничение: Baseline
|
Baseline
|
|
|
Ratio of residual volume / total lung capacity (RV/TLC)
Временное ограничение: Baseline
|
Baseline
|
|
|
Diffusing capacity of the lung for carbon monoxide (DLCO)
Временное ограничение: Baseline
|
Baseline
|
Соавторы и исследователи
Следователи
- Главный следователь: Xavier Soler, MD, PhD, University of California, San Diego
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UCSD130851
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .