Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Days of hospitalization
研究概览
简要总结
Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30 and < 30, using conventional polysomnography. The AHI >=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI <=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.
详细描述
The AHI >=30 group will be analyzed to CPAP, NIV or life style modification treatments for two mouths.Once an evaluation is done during this period, the life style modification treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 and 80 years old.
- •Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
- •Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
- •Absence of narcolepsy or restless legs syndrome
- •Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.
排除标准
- •Psychophysical incapacity to answer questionnaires.
- •Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
- •Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
- •Informed consent not obtained.
研究组 & 干预措施
2
CPAP for severe OSA group
干预措施: life style modification, noninvasive ventilation, CPAP (Device)
1
NIV for severe OSA group
干预措施: life style modification, noninvasive ventilation, CPAP (Device)
3
Life stile modification for severe OSA group
干预措施: life style modification, noninvasive ventilation, CPAP (Device)
4
NIV for non-severe OSA group
干预措施: life style modification, noninvasive ventilation, CPAP (Device)
5
Life stile modification for non-severe OSA group
干预措施: life style modification, noninvasive ventilation, CPAP (Device)
结局指标
主要结局
Days of hospitalization
时间窗: at least three years
Days of hospitalization
PaCO2
时间窗: at the end of first two months
PaCO2
次要结局
- Number of Dropouts for Medical reasons and mortality(at least three years)
- quality of life(two months and three years)
- respiratory function(two months and three years)
- polysomnographic parameters(two months)
- molecular inflammation and endothelial dysfunction(two months and three years)
- echocardiographic parameters(two months and three years)
- Blood pressure and new cardiovascular events(three years)
研究者
Juan F. Masa
MD
Sociedad Española de Neumología y Cirugía Torácica
