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临床试验/NCT04443361
NCT04443361Unknown不适用

Insomnia After the COVID-19 Pandemic

University of Oslo0 个研究点目标入组 5,000 人开始时间: 2020年6月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
主要终点
Bergen insomnia scale (BIS)

研究概览

简要总结

The aim of this study is to investigate the levels of insomnia 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and before the COVID-19 pandemic are associated with sleep problems at T2.

详细描述

Hypothesis/Research Questions H1: What is the level of mental insomnia following three months of strict mitigation strategies (i.e., physical distancing) in the general adult population during the COVID-19 pandemic? The mean level of insomnia will be benchmarked against the mean level of insomnia in similar pre-pandemic samples.

Exploratory: What is the level of insomnia in different demographic subgroups.

H2: The level of metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T2 will predict insomnia at T2, beyond and above, age, gender, and education.

Exploratory: Does metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T1 predict Insomnia at T2, beyond and above psychiatric diagnosis, age, gender, and education and predictors at T2?

Statistical analysis:

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

  • Eligible participants are all adults including those of 18 years and above,
  • Who are currently living in Norway and thus experiencing identical NPIs, and
  • Who had provided digital consent to partake in the study.

排除标准

  • Children and adolescents (individuals below 18) Adults not residing in Norway during the measurement period

结局指标

主要结局

Bergen insomnia scale (BIS)

时间窗: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)

次要结局

未报告次要终点

研究者

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

Sverre Urnes Johnson

Associate Professer Sverre Urnes Johnson

University of Oslo

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Insomnia After the COVID-19 Pandemic | 临床试验