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Fatigue and Sleep in Patients With COVID-19

Fatigue and Sleep in Patients With COVID-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04657419
Acronym
COFATSOM
Enrollment
60
Registered
2020-12-08
Start date
2021-03-08
Completion date
2021-06-13
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID-19, fatigue

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.

Interventions

OTHERsurvey

Self-questionnaires will be completed by the participants : * General health and mental health * Fatigue * Burn-Out * Sleepiness * Sleep hygiene * Symptoms of COVID

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Severity Scaleone 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

MeasureTime frameDescription
COVID Diagnosisinclusion (T0)Diagnosis of COVID-19 by nasopharyngeal PCR
Fatigue evolutionInclusion (T0) and one month afterFatigue 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 hygieneInclusion (T0) and one month afterSleep hygiene measured with questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026