Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- change of mean pulmonary artery pressure measured by echo
研究概览
简要总结
All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
Echocardiography:
It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.
Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (>55 mmHg) degrees.
Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).
排除标准
- •Patients aged < 18 years
- •Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders.
- •Patients on long term oxygen therapy (LTOT).
- •Patients with respiratory neuromuscular weaknesses or chest wall deformities.
- •End-organ failure and malignancies
- •Obesity hypoventilation syndrome.
结局指标
主要结局
change of mean pulmonary artery pressure measured by echo
时间窗: 3 months
次要结局
- Exercise capacity improvement measured by maximun o2 consumption(3 months)
- Exercise capacity improvement measured by six minute walking test(3 months)
研究者
Ahmad Abbas
Lecturer of chest diseases
Zagazig University