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临床试验/NCT01071421
NCT01071421已完成不适用

Prevalence of Sleep Apnea-hypopnea Syndrome in Patients With Community Acquired Pneumonia, Prospective and Comparative Case-control Study

Hospital Universitario San Juan de Alicante1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
123
试验地点
1
主要终点
To evaluate the prevalence of sleep anea-hypopnea syndrome in patients with community acquired pneumonia, defined by an apnea-hypopnea index more to 12 measured by respiratory polygraphy

研究概览

简要总结

The association of sleep apnea-hypopnea syndrome (SAHS) with the infections of the lower airway has not been studied. The aspiration of secretions of the upper airway and the colonization by microorganisms is considered a main event in most of the cases of community acquired pneumonia (CAP) , and specially in the nosocomial pneumonia. The silent aspiration to the lower airway is a common phenomenon in normal subjects during the sleep and some studies has reported that the patients with SAHS present an increase of the risk to pharyngeal aspirations. In fact, the presence of nasal and bronchial inflammation in patients with SAHS is a recognized event. The patients with SAHS could have a risk increased to develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways during the sleep and other mechanical factors associated. The prevalence of SAHS in patients with CAP could be increased as regards the data published for the same Spanish population. The presence of an apnea-hypopnea index (AHI) could be a risk factor not only to to CAP but to to present a unfavorable clinical evolution in comparison to patients with CAP with a normal AHI. The aim of this study will establish a relation between SAHS and the pneumonia risk.

详细描述

This is a prospective comparative case control study to compare the prevalence of sleep apnea-hypopnea syndrome in patients with community acquired pneumonia (CAP).

Patients hospitalized with CAP (Group A)will be studied with respiratory polygraphy during the sleep and a second respiratory polygraphy will be conducted in home after the curation of the pneumonia (one month). During the admission, etiological study including blood cultures, serology, urinary antigens for legionella and S, pneumoniae, sputum cultures and other invasive techniques as bronchoscopy when appropriate will be obtained. Questionnaires related with sleep apnea-hypopnea syndrome will be obtained consisting in Epworth test, symptoms questionnaires and FOSQ test.

Group B are patients with other infections as urinary, bone, pelvic infections excluding upper or lower respiratory infections. Respiratory polygraphy will be performed in this group as in the group A obtaining the same questionnaires.

We compare the variables of respiratory polygraphy, questionnaires scores, percentage of patients with an AHI > 12 between both groups and we compare the variables obtained in the respiratory polygraphy performed in hospital and at home in the group A to evaluate if the condition of an altered AHI was previous to the CAP episode. We will obtain the prevalence of sleep apnea-hypopnea patients in both groups and we compare factor risks (COPD, diabetes mellitus, bronchial asthma, etc) between A and B. Finally multivariable analysis is conducted to evaluate the contribution of the AHI to CAP, as other recognize factor risk.

Both groups are paired by age, sex and body mass index

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Hospital admission and Community acquired pneumonia

排除标准

  • Nosocomial infections
  • Low level of conscientiousness
  • Neurological disease
  • Impossibility to complete the questionnaires
  • Inclusion Criteria:
  • Hospital admission and other infections different to respiratory infections

结局指标

主要结局

To evaluate the prevalence of sleep anea-hypopnea syndrome in patients with community acquired pneumonia, defined by an apnea-hypopnea index more to 12 measured by respiratory polygraphy

时间窗: 2 years

次要结局

  • To evaluate if a high apnea-hypopnea index is observed in patients with community acquired pneumonia and if is maintained after the pneumonia resolution(2 years)
  • To evaluate if the apnea-hypopnea index is a factor risk to community acquired pneumonia(2 years)

研究者

发起方
Hospital Universitario San Juan de Alicante
申办方类型
Other

研究点 (1)

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