Fatigue and Sleep in Patients With COVID-19

NCT04657419 | Completed

• 1 other identifier: CHUBX 2020/52
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19; fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• COVID Diagnosis

  inclusion (T0)

• Fatigue evolution

  Inclusion (T0) and one month after

• Sleep hygiene

  Inclusion (T0) and one month after

Study Arms (1)

Participant

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

Other: survey

Interventions

survey OTHER

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

Participant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient or healthcare professional going to screening center to perform a PCR test for COVID-19

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

COVID-19; Fatigue

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 8, 2020
• Study Start: March 8, 2021
• Primary Completion: June 13, 2021
• Study Completion: June 13, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)