Sleep Apnea Screening
2015年11月2日 更新者：Arrhythmia Network Technology S.L.
Sleep Apnea-Hypopnea Syndrome Screening
To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.
研究概览
地位
终止
研究类型
观察性的
注册 (实际的)
15
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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Badajoz、西班牙
- Hospital Infanta Cristina
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Burgos、西班牙
- Hospital Universitario de Burgos
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Ciudad Real、西班牙
- Hospital General Universitario de Ciudad Real
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Madrid、西班牙
- Hospital Clinico Universitario San Carlos
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Madrid、西班牙
- Hospital Universitario La Paz
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Madrid、西班牙
- Hospital Universitario Puerta de Hierro
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Madrid、西班牙
- HM hospitales
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Madrid、西班牙
- Hospital Universitario de Fuenlabrada
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Ávila、西班牙
- Hospital Nuestra Senora de Sonsoles
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients to be included in the registry:
- 200 patients with pacemaker indication in whom a pacemaker with sleep apnea monitoring system has been implanted.
- 100 patients with pacemaker indication in whom a pacemaker with no sleep apnea monitoring system has been implanted.
- 100 patients with ICD or CRDT therapy indication.
- 100 patients with heart failure and preserved LVEF (40-50%).
- 100 patients with heart failure and reduced LVEF (<40%).
描述
Inclusion Criteria:
- Age 18 years or older
- No previous diagnosis of sleep apnea
Fulfilling at least one of the following:
- Pacemaker indication
- ICD or CRTD therapy indication
- Heart failure and preserved LVEF (40-50%)
- Heart failure and reduced LVEF (<40%)
- Signed informed consent
Exclusion Criteria:
- Age younger than 18 years
- Renal hemodialysis
- Cardiac transplant indication
- Women who are pregnant
- Advanced cancer
- Enrollment in another investigational study
- Able and willing to comply with all testing and requirements
- Patient not suitable for inclusion due to psychiatric conditions or short life expectancy
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Group 1
Patients with pacemaker indication (pacemaker already implanted or to be implanted)
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Group 2
Patients with ICD or CRTD therapy indication (device already implanted or to be implanted)
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Group 3
Patients with heart failure an preserved LVEF (40-50%)
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Group 4
Patients with heart failure and reduced LVEF (<40%)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of patients with SAHS in patients with pacemaker indication
大体时间：1 month
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1 month
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Percentage of patients with SAHS in patients with ICD or CRTD therapy
大体时间：1 month
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1 month
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Percentage of patients with SAHS in patients with heart failure and preserved LVEF
大体时间：1 month
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1 month
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Percentage of patients with SAHS in patients with reduced LVEF
大体时间：1 month
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1 month
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Percentage of patients with obstructive sleep apnea in all groups
大体时间：1 month
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1 month
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Percentage of patients with central sleep apnea in all groups
大体时间：1 month
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1 month
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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。
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
- Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8. doi: 10.1016/j.ijcard.2004.12.068.
- Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
- Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Marshall NS, Wong KK, Liu PY, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008 Aug;31(8):1079-85.
- Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
- Ronald J, Delaive K, Roos L, Manfreda J, Bahammam A, Kryger MH. Health care utilization in the 10 years prior to diagnosis in obstructive sleep apnea syndrome patients. Sleep. 1999 Mar 15;22(2):225-9. doi: 10.1093/sleep/22.2.225.
- Fietze I, Rottig J, Quispe-Bravo S, Riedel F, Witte J, Baumann G, Witt C. Sleep apnea syndrome in patients with cardiac pacemaker. Respiration. 2000;67(3):268-71. doi: 10.1159/000029509.
- Garrigue S, Pepin JL, Defaye P, Murgatroyd F, Poezevara Y, Clementy J, Levy P. High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study. Circulation. 2007 Apr 3;115(13):1703-9. doi: 10.1161/CIRCULATIONAHA.106.659706. Epub 2007 Mar 12.
- Pepin JL, Chouri-Pontarollo N, Tamisier R, Levy P. Cheyne-Stokes respiration with central sleep apnoea in chronic heart failure: proposals for a diagnostic and therapeutic strategy. Sleep Med Rev. 2006 Feb;10(1):33-47. doi: 10.1016/j.smrv.2005.10.003. Epub 2005 Dec 22.
- Tremel F, Pepin JL, Veale D, Wuyam B, Siche JP, Mallion JM, Levy P. High prevalence and persistence of sleep apnoea in patients referred for acute left ventricular failure and medically treated over 2 months. Eur Heart J. 1999 Aug;20(16):1201-9. doi: 10.1053/euhj.1999.1546.
- Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
- Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
- Arias MA, Garcia-Rio F, Alonso-Fernandez A, Sanchez AM. [Sleep apnea-hypopnea syndromes and heart failure]. Rev Esp Cardiol. 2007 Apr;60(4):415-27. Spanish.
- Kasai T, Bradley TD. Obstructive sleep apnea and heart failure: pathophysiologic and therapeutic implications. J Am Coll Cardiol. 2011 Jan 11;57(2):119-27. doi: 10.1016/j.jacc.2010.08.627.
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
2015年6月1日
初级完成 (预期的)
2016年3月1日
研究注册日期
首次提交
2015年10月6日
首先提交符合 QC 标准的
2015年10月6日
首次发布 (估计)
2015年10月7日
研究记录更新
最后更新发布 (估计)
2015年11月3日
上次提交的符合 QC 标准的更新
2015年11月2日
最后验证
2015年11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.