Alternative of Treatment in Obesity Hypoventilation Syndrome
2017年9月22日 更新者:Juan F. Masa、Sociedad Española de Neumología y Cirugía Torácica
Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
440
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Cáceres、西班牙、10003
- Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 80年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:1
NIV for severe OSA group
|
life style modification, noninvasive ventilation, CPAP
|
|
有源比较器:2
CPAP for severe OSA group
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life style modification, noninvasive ventilation, CPAP
|
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有源比较器:3
Life stile modification for severe OSA group
|
life style modification, noninvasive ventilation, CPAP
|
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有源比较器:4
NIV for non-severe OSA group
|
life style modification, noninvasive ventilation, CPAP
|
|
有源比较器:5
Life stile modification for non-severe OSA group
|
life style modification, noninvasive ventilation, CPAP
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Days of hospitalization
大体时间:at least three years
|
Days of hospitalization
|
at least three years
|
|
PaCO2
大体时间:at the end of first two months
|
PaCO2
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at the end of first two months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Dropouts for Medical reasons and mortality
大体时间:at least three years
|
Number of Dropouts for Medical reasons and mortality
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at least three years
|
|
quality of life
大体时间:two months and three years
|
quality of life
|
two months and three years
|
|
respiratory function
大体时间:two months and three years
|
respiratory function
|
two months and three years
|
|
polysomnographic parameters
大体时间:two months
|
polysomnographic parameters
|
two months
|
|
molecular inflammation and endothelial dysfunction
大体时间:two months and three years
|
molecular inflammation and endothelial dysfunction
|
two months and three years
|
|
echocardiographic parameters
大体时间:two months and three years
|
echocardiographic parameters
|
two months and three years
|
|
Blood pressure and new cardiovascular events
大体时间:three years
|
Blood pressure and new cardiovascular events
|
three years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Juan F Masa, MD、Hospital San Pedro de Alcántara. Cáceres. Spain
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Masa JF, Benitez ID, Javaheri S, Mogollon MV, Sanchez-Quiroga MA, de Terreros FJG, Corral J, Gallego R, Romero A, Caballero-Eraso C, Ordax-Carbajo E, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Barbe F, Mokhlesi B; Spanish Sleep Network. Risk factors associated with pulmonary hypertension in obesity hypoventilation syndrome. J Clin Sleep Med. 2022 Apr 1;18(4):983-992. doi: 10.5664/jcsm.9760.
- Masa JF, Benitez I, Sanchez-Quiroga MA, Gomez de Terreros FJ, Corral J, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Mokhlesi B; Spanish Sleep Network. Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial. Chest. 2020 Sep;158(3):1176-1186. doi: 10.1016/j.chest.2020.03.068. Epub 2020 Apr 25.
- Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros Caro FJ, Sanchez-Quiroga MA, Romero A, Caballero C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral-Penafiel J; Spanish Sleep Network. Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea. Thorax. 2020 Jun;75(6):459-467. doi: 10.1136/thoraxjnl-2019-213622. Epub 2020 Mar 26.
- Masa JF, Mokhlesi B, Benitez I, Mogollon MV, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Echocardiographic Changes with Positive Airway Pressure Therapy in Obesity Hypoventilation Syndrome. Long-Term Pickwick Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 1;201(5):586-597. doi: 10.1164/rccm.201906-1122OC.
- Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.
- Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.
- Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network. The Effect of Supplemental Oxygen in Obesity Hypoventilation Syndrome. J Clin Sleep Med. 2016 Oct 15;12(10):1379-1388. doi: 10.5664/jcsm.6194.
- Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, Sanchez-Quiroga MA, Ordax E, Gonzalez-Mangado N, Troncoso MF, Martinez-Martinez MA, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramon MA, Diaz-de-Atauri J, Munoz-Mendez J, Senent C, Sancho-Chust JN, Ribas-Solis FJ, Romero A, Benitez JM, Sanchez-Gomez J, Golpe R, Santiago-Recuerda A, Gomez S, Bengoa M. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. 2016 Oct;71(10):899-906. doi: 10.1136/thoraxjnl-2016-208501. Epub 2016 Jul 12.
- Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.
- Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年5月1日
初级完成 (实际的)
2013年5月1日
研究完成 (实际的)
2017年7月1日
研究注册日期
首次提交
2008年7月3日
首先提交符合 QC 标准的
2011年7月28日
首次发布 (估计)
2011年7月29日
研究记录更新
最后更新发布 (实际的)
2017年9月25日
上次提交的符合 QC 标准的更新
2017年9月22日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.