Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Epworth Sleepiness Scale
研究概览
简要总结
The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC. Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these diseases.
详细描述
Tracheobronchomalacia (TBM) and HyperDynamic Airway Collapse (HDAC) are two distinct airway diseases that lead to airway collapse which can in turn lead to the symptoms of dyspnea, cough, and inability to expectorate sputum effectively. TBM entails flaccid tracheal and bronchial cartilages leading to airway collapse, emanating primarily from the anterior wall of the lumen. It is seen in conditions such as Relapsing Polychondritis and saber sheath tracheal deformity. HDAC on the other hand is the hyper-flaccidity of the membranous portion of the tracheobronchial tree leading to airway collapse. This condition is commonly seen with obesity and severe emphysema. TBM and HDAC frequently coexist.
In patients with TBM/HDAC sleep disorders are common. Patients often complain of poor quality sleep, snoring, daytime fatigue, and somnolence. These patients are often diagnosed with Obstructive Sleep Apnea (OSA) upon workup.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males ages 18-80 years old
- •Able and willing to provide written informed consent
- •Existing diagnosis of TBM or HDAC or both
- •No pre-existing diagnosis of OSA
- •No history of reconstructive surgery of chest wall or diaphragm
排除标准
- •Inability to provide informed consent
- •Non-English speaking
- •Poorly controlled congestive heart failure
- •Untreated Insomnia
- •Severe Coronary artery disease with active symptoms of angina
- •Patient is pregnant, or plans to become pregnant in next 3 months
- •Moderate to severe bronchiectasis
- •Severe untreated gastroesophageal disease (GERD).
- •Moderate to large hiatal hernia deemed to be atleast in part responsible for TBM/HDAC
- •Airway obstruction not caused by TBM /HDAC or secondary TBM/HDAC caused by conditions such as Chronic Obstructive Pulmonary Disease (COPD).
- •Active or recent (with in last one year) cancer or cancer therapy (chemotherapy, radiation therapy or surgery)
- •Inability to properly perform the home sleep test
- •Unreliable test data after 2 attempts
结局指标
主要结局
Epworth Sleepiness Scale
时间窗: Baseline
The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
次要结局
未报告次要终点