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临床试验/NCT04113876
NCT04113876已完成不适用

Circadian Health in Patients Admitted to Intensive Care Units and Hospitalization (CHRONOHOSPI)

Instituto de Salud Carlos III1 个研究点 分布在 1 个国家目标入组 975 人开始时间: 2019年1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
975
试验地点
1
主要终点
Circadian Health

研究概览

简要总结

This study evaluates the quality of sleep of patients admitted to medical and intensive care units. All of them will have a clock placed to measure their circadian activity. Also, data will be recorded through questionnaires about the unit, patient habits and medical problems.

详细描述

The investigators found an extensive bibliography related to the quality of sleep and its effects on health. However, it should be noted the literary emptiness in relation to the influential factors in it. Chronobiology is the science responsible for studying the rhythmic changes in living beings; where the investigators include the circadian rhythm. In this way, all the "cycles" will be influenced by a series of factors that allow its correct operation, being in this case the light-dark cycle (LD), together with the temperature compensation, these being the determinants that allow, or not homeostasis.

The sleep - wake pattern is one of the most important circadian rhythms that happen in the organism. The dream is an unconscious process by which, despite the muscular relaxation that occurs, it is accompanied by continuous brain activity along with sensitive perception, where several of the organ systems come into play. This cycle is composed of two factors: a homeostatic one directly proportional to the time we are awake, and another circadian, dependent on the secretion of melatonin and the body's regulation of temperature. This fact can be compromised by the appearance of both external and internal stimuli, altering normal functioning, which is translated into sleep deprivation, which, if extended over time, can have physical and mental consequences, Some of them are: deterioration of the immune function, an increase in the incidence of cardiovascular diseases, memory deficit, early aging, mood swings, difficulty in healing, greater probability of developing metabolic syndromes, cognitive, affective disorders and even some types of cancer

The results obtained will facilitate the elaboration of action protocols focused on improving sleep quality in hospitalized patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • subjects over 18 years of age, minimum duration of the hospitalization process of 96h, conscious and oriented with constancy in their clinical history (HC) and who give their consent.

排除标准

  • personas con discapacidad visual y/o auditiva documentada en su HC, en el caso de los pacientes de Unidades de Cuidados Intensivos (UCIs) se excluirán a aquellos que obtengan una puntuación inferior a 8 en la escala Glasgow. Pacientes con cualquier tipo de aislamiento y aquellos incluidos en el plan de Cuidados Paliativos.

结局指标

主要结局

Circadian Health

时间窗: 96 hours

Using the KRONOHEALTH® recording device, we will measure the following indicators: * Total Sleep Time * Sleep Fragmentations * Sleep depth * Chronobiological health index

次要结局

  • Subjective Sleep Quality(1 day (one time evaluation))
  • Degree of sleep interference during hospitalization(1 day (one time evaluation))

研究者

发起方
Instituto de Salud Carlos III
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Teresa Moreno Casbas

Doctor, Clinical Research

Instituto de Salud Carlos III

研究点 (1)

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