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临床试验/NCT01877616
NCT01877616已完成不适用

Population-bases Study to Asses Prevalence of Sleep Disorders and Their Association With Cardiovascular Risk Factors and Diseases

Hospital Clínica Kennedy2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
650
试验地点
2
主要终点
prevalence of sleep disorders

研究概览

简要总结

Little is known on the prevalence of sleep disorders and their role in the increased prevalence of cardiovascular diseases in the developing world. We To assess the prevalence of major sleep disorders in a rural South American population, and to determine whether these conditions are associated with a poor cardiovascular health or with the occurrence of stroke or ischemic heart disease. This is a three-phase, population-based, door-to-door survey in Atahualpa. During phase I, all residents aged ≥40 years will be screened with validated Spanish versions of five questionnaires to evaluate major sleep disorders. In phase II, neurologists will examine persons suspected of having a sleep disorder and a random sample of negative individuals to assess the prevalence of these conditions and to validate the accuracy of questionnaires. In phase III, patients with a confirmed sleep disorder will undergo nocturnal polysomnography for achieving a more specific diagnosis. The occurrence of sleep disorders will be correlated with the cardiovascular health of the population as well as with the presence of stroke and ischemic heart disease. This epidemiological study may prove cost-effective in improving sleep conditions of people living in rural areas of developing countries, and may be used as a model for the evaluation of sleep disorders and their cardiovascular correlates in these populations.

详细描述

For the purposes of the present part of the Atahualpa Project, field personnel were trained to achieve expertise with the use of the screening questionnaires, and to assure uniformity in data collection. The independent review board of Hospital-Clínica Kennedy (Guayaquil, Ecuador) approved the study design and the informed consent form that has to be signed by all Atahualpa residents aged ≥40 years before enrollment in the study.

Field workers will perform a census of the population to detect all Atahualpa residents aged ≥40 years (including those who were not living at the village by the time of our previous census). Those "new" persons will be interviewed to assess their social and demographic characteristics and to evaluate their CVH status in the same way as it was done with the rest of the population in our most recent survey.

During the current survey, all consented persons will undergo a physical examination with attention to the measurement of the neck circumference, as well as the evaluation of facial characteristics relevant to the coexistence of sleep disorders, including retrognathia, nasal septum deviation, asymmetry of the nares, and palate position. The latter will be evaluated with the tongue resting inside the mouth (using the Friedman classification) and categorized into four classes according to which structures are visible: Grade I allows visualization of the entire uvula and tonsils/pillars, Grade II allows visualization of the uvula but not the tonsils/pillars, Grade III allows visualization of the soft palate but not the uvula, and Grade IV allows visualization of the hard palate only.

From the many questionnaires available for the detection of persons with suspected sleep disorders, our panel agreed to choose those that have been more widely used and have shown to be time-efficient, consistent and reliable for prediction of major sleep disorders. Field instruments include validated Spanish versions of the insomnia severity index, the Pittsburgh sleep quality index, the Epworth sleepiness scale, the Berlin questionnaire, and the four minimal diagnostic criteria for restless legs syndrome.

The insomnia severity index consists of seven questions evaluating nighttime sleep difficulties, sleep dissatisfaction, and impact of insomnia on the quality of life. Time-frame of such evaluation is in the two weeks before the test. Each question is rated on a five-point Likert scale ranging from 0 (not at all) to 4 (extremely) with a maximum total score of 28. Scores from 0 to 7 mean no clinically significant insomnia, 8 to 14 mean subthreshold insomnia, 15 to 21 mean moderate clinical insomnia, and 22 to 28 mean severe clinical insomnia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all Atahualpa residents aged 40 years or more -

排除标准

  • persons not signing the informed consent form

结局指标

主要结局

prevalence of sleep disorders

时间窗: five years

prevalence of sleep disorders will be assessed by a door-to-door survey. Then, sleep-certified specialists will move to Atahualpa to evaluate suspected persons, and positive cases will undergo polysomnography

次要结局

  • correlation of sleep disorders with the presence of cardiovascular risk factors, stroke, and ischemic heart disease(five years)

研究者

发起方
Hospital Clínica Kennedy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar H. Del Brutto, MD

Research Professor

Hospital Clínica Kennedy

研究点 (2)

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