Fatigue and Sleep in Patients With COVID-19

Covid19 Clinical Trial

— COFATSOM  

Official title:

Fatigue and Sleep in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657419
• Other study ID #: CHUBX 2020/52
• Status: Completed
• Start date: March 8, 2021
• Est. completion date: June 13, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 13, 2021
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Fatigue

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale	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	one month after inclusion (T0)
Secondary	COVID Diagnosis	Diagnosis of COVID-19 by nasopharyngeal PCR	inclusion (T0)
Secondary	Fatigue evolution	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	Inclusion (T0) and one month after
Secondary	Sleep hygiene	Sleep hygiene measured with questionnaire	Inclusion (T0) and one month after