Covid19COFATSOMNCT04657419
Fatigue and Sleep in Patients With COVID-19
An observational study of Covid19, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- survey
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2021to 13 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient or healthcare professional going to screening center to perform a PCR test for COVID-19
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- survey
- Keywords
- COVID-19, fatigue
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
Self-questionnaires will be completed by the participants :
- General health and mental health
- Fatigue
- Burn-Out
- Sleepiness
- Sleep hygiene
- Symptoms of COVID
| Study group | Role | What they receive |
|---|---|---|
| Participant | Patient or health professional coming to the Bordeaux University Hospital screening center for COVID-19 screening Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month after inclusion (T0)
Secondary outcomes (3)
COVID Diagnosis
Diagnosis of COVID-19 by nasopharyngeal PCR
Measured: inclusion (T0)
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
Measured: Inclusion (T0) and one month after
Sleep hygiene
Sleep hygiene measured with questionnaire
Measured: Inclusion (T0) and one month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start8 Mar 2021
- Primary completion13 Jun 2021
- Study completion13 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657419
- Sponsor's protocol ID
- CHUBX 2020/52
- Acronym
- COFATSOM
- Status last verified
- Jun 2021
- First submitted
- 7 Dec 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Sleep in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04657419
- Acronym / sponsor ID
- COFATSOM / CHUBX 2020/52
- Conditions
- Covid19
- Keywords
- COVID-19, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 13 Jun 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Other: surveyPatient or health professional coming to the Bordeaux University Hospital screening center for COVID-19 screening |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient or healthcare professional going to screening center to perform a PCR test for COVID-19
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveySelf-questionnaires will be completed by the participants : * General health and mental health * Fatigue * Burn-Out * Sleepiness * Sleep hygiene * Symptoms of COVID | Other | Participant |
Primary outcome
Fatigue Severity Scale
Time frame: 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
3 secondary outcomes
COVID Diagnosis
Time frame: inclusion (T0)
Fatigue evolution
Time frame: Inclusion (T0) and one month after
Sleep hygiene
Time frame: Inclusion (T0) and one month after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: one month after inclusion (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.