Analysis of the Determinants of Sleep Quality in a Spanish Population. a Study Protocol for a Cross-sectional Study
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
- 是
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
José Ignacio Recio Rodriguez
PhD, Associate Professor
University of Salamanca
