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临床试验/NCT04657419
NCT04657419已完成不适用

Fatigue and Sleep in Patients With COVID-19

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月8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
60
试验地点
1
主要终点
Fatigue Severity Scale

研究概览

简要总结

Recent studies show that patients who have contracted COVID-19 retain very significant fatigue after resolving the infectious episode. This fatigue may be explained by low-grade inflammation. There is more data for patients with COVID-19 who have been hospitalized than for non-hospitalized patients with milder forms.

However, COVID-19 related fatigue would not only affect elderly people with severe cardiopulmonary consequences but also young subjects without severities. This notion is not very widespread and to date, COVID contracted by young subjects is considered to have very few consequences on their health.

It is also known that the prevalence of sleep debt is significant in the general population and particularly in young people, and it is also known that sleep deprivation increases low-grade inflammation and facilitates the risk of viral contamination. The association between sleep deprivation, drowsiness and possibly low-grade inflammation raise questions about the mechanisms of fatigue in the general population.

Investigators are also entitled to wonder to what extent the chronic sleep debt suffered by the French population can explain an increased risk of contamination by COVID 19 but also significant residual fatigue after COVID infection.

Bordeaux University Hospital screens 2,000 subjects per day at risk of being infected by COVID, it would be very interesting to measure, in a population of young adults aged 18-45 years, frequently exposed to a sleep debt, sleep hygiene (bedtime and wake-up times, sleep and wake-up schedules, and overall sleep satisfaction), average sleep duration, level of fatigue and drowsiness and to compare these thresholds between subjects with or without COVID 19 according to nasopharyngeal PCR.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient or healthcare professional going to screening center to perform a PCR test for COVID-19
  • Between 18 and 45 years old
  • Symptomatic or not
  • Whether or not COVID-19 contact-case
  • Accepting to participate to the research
  • Informed and having expressly transmitted their non-opposition to participate in the study

排除标准

  • Participants who do not speak French or who cannot read or write
  • Patients who do not have contact information for recall
  • Refusal to participate in the study.
  • Majors under guardianship or curatorship.

结局指标

主要结局

Fatigue Severity Scale

时间窗: one month after inclusion (T0)

Presence of significant fatigue as measured by the Fatigue Severity Scale (FSS) at 1 month. Score from 1 to 7 FSS is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score possible is 63. Higher is the score, greater is the fatigue severity

次要结局

  • COVID Diagnosis(inclusion (T0))
  • Fatigue evolution(Inclusion (T0) and one month after)
  • Sleep hygiene(Inclusion (T0) and one month after)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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