Fatigue and Sleep in Patients With COVID-19

Completed

• Conditions: Covid19
• Interventions: Other: survey

• Registration Number: NCT04657419
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Study Start: 2021-03-08
• Status Verified: 2021-06
• Primary Completion: 2021-06-13
• Study Completion: 2021-06-13
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participant	survey	Patient or health professional coming to the Bordeaux University Hospital screening center for COVID-19 screening

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	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

Secondary Outcome Measures

Name	Time	Method
COVID Diagnosis	inclusion (T0)	Diagnosis of COVID-19 by nasopharyngeal PCR
Fatigue evolution	Inclusion (T0) and one month after	Fatigue measured by Fatigue Severity Scale 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
Sleep hygiene	Inclusion (T0) and one month after	Sleep hygiene measured with questionnaire

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France