Long COVIDPostCoV2OSANCT05290350
Long COVID-19 Fatigue and Obstructive Sleep Apnea
An observational study of Long COVID and Fatigue, run by Centro Hospitalar Universitario do Algarve at 12 sites in Portugal.
Trial summary
Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Long COVID, Fatigue, Obstructive Sleep Apnea of Adult
- What is being tested?
- OSA
- How many people
- 300 participants
- Where
- 12 sitesPortugal
- Study dates
- 10 Mar 2022to 30 Jan 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in twelve Portuguese Hospitals, Universitary and District, in which a follow-up post-COVID-19 medical consultation has been implemented All patients that attend the follow-up post COVID-19 consultation will be invited to participate in the study.
Who may be able to join
- ≥18 years; (2) previous COVID-19 at least six months before the initial study protocol evaluation; (3) persistent symptoms after cure criteria defined by WHO; (4) patients who attend the post-COVID-19 follow-up consultation of the study centers. (5) SARS-CoV-2 infection confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab (6) patients who agree to sign the Written informed consent (following the ethics committee protocol).
Who cannot join
- patients who had a concomitant neurological disorder that could increase OSA risk (such as stroke, Parkinson disease, or amyotrophic lateral sclerosis); (2) patients who were on invasive mechanical ventilation. (3) patients with persistent fatigue symptoms,6 months before SARS-CoV-2 infection (4) patients without SARS-CoV-2 positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Portugal12 sites, 12 recruiting
- Recruiting
Hospital Particular de Alvor
Alvor, 8500-322
Ana Fontes, Prof, 282420400 ext. 775, anafontes@grupohpa.com
Ligia Pires, MD, 282420400 ext. 120, ligiapires@grupohpa.com
- Recruiting
Hospital de Faro (Chua)
Faro, 800-386
Karl Cunha, MD, 289891100, karljonathan@gmail.com
Helena Ramos, MD, 289891100, helena.chaves.ramos@hotmail.com
- Recruiting
Hospital da Luz Guimaraes (HLG)
Guimarães, 4835-23
Maria Jose Guimaraes, MD, +351253420300 ext. 41053, zezaguimaraes@gmail.com
Maria Jose Guimaraes
- Recruiting
Hospital de Santo Andre (Chl)
Leiria, 2410-197
Joao Machado, MD, +351 244 817 056 ext. 3601, joaoneivamachado@gmail.com
SALVATO FEIJO, MD, +351 244 817 055 ext. 5811, sec.pneumologia@chleiria.min-saude.pt
- Not yet recruiting
Hospital Da Luz Lisboa
Lisbon, 1500-650
Sofia Furtado, MD, 21 710 4400, sfurtado@hospitaldaluz.pt
Sofia Furtado, MD
- Recruiting
Hospital de Santa Maria (CHULN)
Lisbon, 1649-028
Paula Pinto, Prof, 217805000 ext. 55395, paulagpinto@gmail.com
Cristina Barbara, Prof, 218430500, pndr@dgs.min-saude.pt
- Not yet recruiting
Hospital Beatriz Angelo (Hba)
Loures, 2674-514
Vera Martins, MD, +351 219 847 240, vera.martins2@hba.min-saude.pt
Margarida Barata, MD, +351 219 847 240, margarida.duarte.barata@hba.min-saude.pt
- Recruiting
Hospital de Portimao (Chua)
Portimão, 8500-338
Ligia Pires, MD, 282450300 ext. 43178, alves1029@hotmail.com
Tania Fatal, 282450300 ext. 35427, taniafatal@hotmail.com
- Recruiting
Hospital Sao Joao (Chusj)
Porto, 4200-319
Marta Drummond, Prof, +351225512100, marta.drummond@gmail.com
Renato Silva, +351225513600, renato.ivos@gmail.com
- Recruiting
Hospital de Sao Sebastiao (Chedv)
Santa Maria da Feira, 4520-211
Ana Sofia Barroso, MD, +351 256 379 700, anasofiabarroso@gmail.com
Jorge Ferreira, Prof, +351 256 379 700, pneumologia@chedv.min-saude.pt
- Recruiting
Centro Hospitalar de Setubal (Chs)
Setúbal, 2910-549
Vera Clerigo, MD, 265 549 085, vera.clerigo@chs-min-saude.pt
Paula Duarte, MD, 265 549 000, secpneumologia@chs.min-saude.pt
- Recruiting
Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)
Vila Real, 5000-508
Bebiana Conde, Prof, 259300500 ext. 4480, bebianaconde@gmail.com
Bebiana Conde, Prof
About this study
Official title: Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study
Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease
Read the detailed description
The presence of fatigue symptoms up to 6-7 months after acute COVID-19 disease, similar to myalgic encephalomyelitis/chronic fatigue syndrome, also observed after other viral infections, have been reported as the most frequent post-COVID-19 symptom (Townsend et al., 2020).
There is a physiological plausibility for OSA being a causal factor to COVID-19 morbidity and fatigue symptoms by nocturnal hypoxemia, exacerbating or causing endothelial dysfunction, inflammation, oxidative stress, microaspiration and cardiac dysfunction. OSA activates the renin-angiotensin-aldosterone system (RAAS) and angiotensin-converting enzyme-2 (ACE2), which is the SARS-CoV-2 entry receptor in the cells (Miller et al., 2021).
In this study we will identify the prevalence of OSA and it's relation with post-COVID-19 fatigue that remains for at least six month after the acute disease, in patients that attend the post-COVID-19 Out Patients Hospital Clinics. It will be studied also the relation between fatigue and vaccination status, nocturnal hypoxemia, day time sleepness and the acute COVID-19 severity.
Data collection will be performed by a questionnaire administered by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation).
Demographic, clinical data and clinical research forms will be collected between 6-7th month after the diagnosis of COVID-19 (t1) and 9 months later (t2).
Fatigue will be assessed using the Chalder fatigue scale - CFQ-11 (Chalter et al., 1993).
The evaluation of OSA related daytime sleepiness will be measured using the Epworth Sleepiness Scale - ESS (Johns, 1991). The OSA diagnosis will be performed using portable monitoring device type III (in-home polygraphy), between 6-7th month after the diagnosis of COVID-19 (t1).
- Conditions
- Long COVID, Fatigue, Obstructive Sleep Apnea of Adult
- Being tested
- OSA
- Keywords
- Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSAOther
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA
| Study group | Role | What they receive |
|---|---|---|
| OSA Cohort | Patients With post COVID-19 condition and OSA Receives: Other: OSA | |
| Control Cohort | Patients With post COVID-19 condition without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-COVID-19 long term fatigue and OSA
Evaluate if untreated OSA is associated with post COVID-19 long term fatigue.
Measured: 6 - 7 months
Secondary outcomes (5)
post-COVID-19 long term fatigue and daytime sleepiness
Evaluate if daytime sleepiness is associated with post COVID-19 long term fatigue.
Measured: 6 - 9 months
post-COVID-19 long term fatigue and nocturnal hypoxemia
Evaluate if nocturnal hypoxemia is associated with post COVID-19 long term fatigue
Measured: 6 - 7 months
post-COVID-19 long term fatigue and severity of acute COVID-19
Evaluate if severity of acute COVID-19 is associated with post COVID-19 long term fatigue
Measured: 6 - 9 months
post-COVID-19 long term fatigue and vaccination status
Study the relation between vaccination status and post-COVID-19 long term fatigue
Measured: 6 - 9 months
Long COVID-19 and OSA impact in quality of life
Study the impact of Long COVID-19 with untreated OSA in quality of life
Measured: 6 - 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start10 Mar 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitario do Algarve
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedade Portuguesa de Pneumologia, Universidade do Algarve, Universidade do Porto, Center for Health Technology and Services Research, Linde Health Care
- Responsible party
- Principal investigator, Ligia Pires, Centro Hospitalar Universitario do Algarve
- Investigators
- Ligia Pires, Study chair, Centro Hospitalar Universitario do Algarve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290350
- Sponsor's protocol ID
- 132/21
- Acronym
- PostCoV2OSA
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.
PubMed 8463991Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Miller MA, Cappuccio FP. A systematic review of COVID-19 and obstructive sleep apnoea. Sleep Med Rev. 2021 Feb;55:101382. doi: 10.1016/j.smrv.2020.101382. Epub 2020 Sep 8.
PubMed 32980614Townsend L, Dyer AH, Jones K, Dunne J, Mooney A, Gaffney F, O'Connor L, Leavy D, O'Brien K, Dowds J, Sugrue JA, Hopkins D, Martin-Loeches I, Ni Cheallaigh C, Nadarajan P, McLaughlin AM, Bourke NM, Bergin C, O'Farrelly C, Bannan C, Conlon N. Persistent fatigue following SARS-CoV-2 infection is common and independent of severity of initial infection. PLoS One. 2020 Nov 9;15(11):e0240784. doi: 10.1371/journal.pone.0240784. eCollection 2020.
PubMed 33166287
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05290350
- Acronym / sponsor ID
- PostCoV2OSA / 132/21
- Conditions
- Long COVID, Fatigue, Obstructive Sleep Apnea of Adult
- Keywords
- Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitario do AlgarveUniversity, hospital or other
- Collaborators
- Sociedade Portuguesa de Pneumologia, Universidade do Algarve, Universidade do Porto, Center for Health Technology and Services Research, Linde Health Care
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 22 Mar 2022 (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.
Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease
Detailed description
The presence of fatigue symptoms up to 6-7 months after acute COVID-19 disease, similar to myalgic encephalomyelitis/chronic fatigue syndrome, also observed after other viral infections, have been reported as the most frequent post-COVID-19 symptom (Townsend et al., 2020).
There is a physiological plausibility for OSA being a causal factor to COVID-19 morbidity and fatigue symptoms by nocturnal hypoxemia, exacerbating or causing endothelial dysfunction, inflammation, oxidative stress, microaspiration and cardiac dysfunction. OSA activates the renin-angiotensin-aldosterone system (RAAS) and angiotensin-converting enzyme-2 (ACE2), which is the SARS-CoV-2 entry receptor in the cells (Miller et al., 2021).
In this study we will identify the prevalence of OSA and it's relation with post-COVID-19 fatigue that remains for at least six month after the acute disease, in patients that attend the post-COVID-19 Out Patients Hospital Clinics. It will be studied also the relation between fatigue and vaccination status, nocturnal hypoxemia, day time sleepness and the acute COVID-19 severity.
Data collection will be performed by a questionnaire administered by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation).
Demographic, clinical data and clinical research forms will be collected between 6-7th month after the diagnosis of COVID-19 (t1) and 9 months later (t2).
Fatigue will be assessed using the Chalder fatigue scale - CFQ-11 (Chalter et al., 1993).
The evaluation of OSA related daytime sleepiness will be measured using the Epworth Sleepiness Scale - ESS (Johns, 1991). The OSA diagnosis will be performed using portable monitoring device type III (in-home polygraphy), between 6-7th month after the diagnosis of COVID-19 (t1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA Cohort | – | Other: OSAPatients With post COVID-19 condition and OSA |
| Control Cohort | – | –Patients With post COVID-19 condition without OSA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in twelve Portuguese Hospitals, Universitary and District, in which a follow-up post-COVID-19 medical consultation has been implemented All patients that attend the follow-up post COVID-19 consultation will be invited to participate in the study.
Key inclusion criteria (1 listed)
- ≥18 years; (2) previous COVID-19 at least six months before the initial study protocol evaluation; (3) persistent symptoms after cure criteria defined by WHO; (4) patients who attend the post-COVID-19 follow-up consultation of the study centers. (5) SARS-CoV-2 infection confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab (6) patients who agree to sign the Written informed consent (following the ethics committee protocol).
Key exclusion criteria (1 listed)
- patients who had a concomitant neurological disorder that could increase OSA risk (such as stroke, Parkinson disease, or amyotrophic lateral sclerosis); (2) patients who were on invasive mechanical ventilation. (3) patients with persistent fatigue symptoms,6 months before SARS-CoV-2 infection (4) patients without SARS-CoV-2 positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab
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 |
|---|---|---|
| OSAEXPOSURE TO OBSTRUCTIVE SLEEP APNEA | Other | OSA Cohort |
Primary outcome
post-COVID-19 long term fatigue and OSA
Time frame: 6 - 7 months
Evaluate if untreated OSA is associated with post COVID-19 long term fatigue.
5 secondary outcomes
post-COVID-19 long term fatigue and daytime sleepiness
Time frame: 6 - 9 months
post-COVID-19 long term fatigue and nocturnal hypoxemia
Time frame: 6 - 7 months
post-COVID-19 long term fatigue and severity of acute COVID-19
Time frame: 6 - 9 months
post-COVID-19 long term fatigue and vaccination status
Time frame: 6 - 9 months
Long COVID-19 and OSA impact in quality of life
Time frame: 6 - 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 8463991Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.
- Background: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Background: PubMed 32980614Miller MA, Cappuccio FP. A systematic review of COVID-19 and obstructive sleep apnoea. Sleep Med Rev. 2021 Feb;55:101382. doi: 10.1016/j.smrv.2020.101382. Epub 2020 Sep 8.
- Background: PubMed 33166287Townsend L, Dyer AH, Jones K, Dunne J, Mooney A, Gaffney F, O'Connor L, Leavy D, O'Brien K, Dowds J, Sugrue JA, Hopkins D, Martin-Loeches I, Ni Cheallaigh C, Nadarajan P, McLaughlin AM, Bourke NM, Bergin C, O'Farrelly C, Bannan C, Conlon N. Persistent fatigue following SARS-CoV-2 infection is common and independent of severity of initial infection. PLoS One. 2020 Nov 9;15(11):e0240784. doi: 10.1371/journal.pone.0240784. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ligia Pires study chair
Centro Hospitalar Universitario do Algarve
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Fatigue, run by Centro Hospitalar Universitario do Algarve at 12 sites in Portugal.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ligia Pires (+351282450300 ext. 43168, alves1029@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-COVID-19 long term fatigue and OSA (time frame: 6 - 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290350, which also lists 4 linked publications.
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 6 Apr 2022.