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临床试验/NCT05324267
NCT05324267已完成不适用

Analysis of the Determinants of Sleep Quality in a Spanish Population. a Study Protocol for a Cross-sectional Study

University of Salamanca1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022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
入组人数
500
试验地点
1
主要终点
Sleep quality

研究概览

简要总结

Introduction: Sleep disorders are a growing concern for public health, being related, among others, to an increased risk of cardiovascular diseases or poorer cognitive functioning. In addition, these might have a possible impact on aspects related to personal motivation and quality of life. However, few studies have analyzed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these.

Objective: To evaluate the determinants of sleep quality in a representative sample of the general adult population aged 25 to 65 years old and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities and biological markers.

Methodology:

Design: This is a descriptive observational, cross-sectional study that will include a representative sample of 500 people aged 25 to 65 years old from the city of Salamanca (Spain) selected by random sampling stratified by age and sex.

Study variables: A visit lasting approximately 90 minutes will be carried out. The determinants of sleep quality will be assessed using both objective and self-reported methods. Variables related to life styles will be assessed: physical activity, diet and toxic habits including tobacco smoking or alcohol use. Morbidity data will also be collected, and psychological factors such as anxiety will also be assessed. Serum melatonin levels will be determined as a biological marker related to sleep quality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 25-65 years old
  • Sign the informed consent

排除标准

  • Patients with terminal disease
  • Any clinical condition that would interfere with study procedures

结局指标

主要结局

Sleep quality

时间窗: Baseline

Measured by the Pittsburgh Sleep Quality Index (PSQI). Possible scores on the PSQI range from 0 (no difficulty) to 21 (severe difficulties in all areas).

次要结局

  • Alcohol use(Baseline)
  • Serum melatonin levels(Baseline)
  • Diet(Baseline)
  • Physical activity(Baseline)
  • Tobacco smoking(Baseline)
  • Anxiety(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Ignacio Recio Rodriguez

PhD, Associate Professor

University of Salamanca

研究点 (1)

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