COFATSOM: Fatigue and Sleep in Patients With COVID-19

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT04657419

Collaborator

(none)

Enrollment

Location

3.2

Actual Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: survey

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Fatigue and Sleep in Patients With COVID-19

Actual Study Start Date :

Mar 8, 2021

Actual Primary Completion Date :

Jun 13, 2021

Actual Study Completion Date :

Jun 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Participant Patient or health professional coming to the Bordeaux University Hospital screening center for COVID-19 screening	Other: survey Self-questionnaires will be completed by the participants : General health and mental health Fatigue Burn-Out Sleepiness Sleep hygiene Symptoms of COVID

Arm

Intervention/Treatment

Participant

Patient or health professional coming to the Bordeaux University Hospital screening center for COVID-19 screening

Other: survey

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bordeaux	Bordeaux		France

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT04657419

Other Study ID Numbers:

CHUBX 2020/52

First Posted:

Dec 8, 2020

Last Update Posted:

Jun 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Bordeaux

COVID-19

fatigue

Additional relevant MeSH terms:

COVID-19

Fatigue

Study Results

No Results Posted as of Jun 16, 2021