Clinical trial NCT04657419: Fatigue and Sleep in Patients With COVID-19
Official title: Fatigue and Sleep in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
fatigue
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient or healthcare professional going to screening center to perform a PCR test for COVID-19

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: one month after inclusion (T0)
Secondary outcomes:
measure: COVID Diagnosis
timeFrame: inclusion (T0)
measure: Fatigue evolution
timeFrame: Inclusion (T0) and one month after
measure: Sleep hygiene
timeFrame: Inclusion (T0) and one month after
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: