Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sociedade Portuguesa de Pneumologia | OTHER |
| Universidade do Algarve | OTHER |
| Universidade do Porto | OTHER |
| Center for Health Technology and Services Research |
Not provided
Not provided
Not provided
Not provided
Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA Cohort | Patients With post COVID-19 condition and OSA |
| |
| Control Cohort | Patients With post COVID-19 condition without OSA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSA | Other | EXPOSURE TO OBSTRUCTIVE SLEEP APNEA |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-COVID-19 long term fatigue and OSA | Evaluate if untreated OSA is associated with post COVID-19 long term fatigue. | 6 - 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| post-COVID-19 long term fatigue and daytime sleepiness | Evaluate if daytime sleepiness is associated with post COVID-19 long term fatigue. | 6 - 9 months |
| post-COVID-19 long term fatigue and nocturnal hypoxemia |
Not provided
Inclusion Criteria:
(1) ≥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).
Exclusion Criteria:
(1) 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
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligia Pires | Contact | +351282450300 | 43168 | alves1029@hotmail.com |
| Tania Fatal | Contact | +351282450300 | 35427 | taniafatal@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ligia Pires | Centro Hospitalar Universitario do Algarve | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Particular de Alvor | Recruiting | Alvor | 8500-322 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8463991 | Background | 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. | |
| 1798888 | Background | Johns 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| OTHER |
| Linde Health Care | OTHER |
Not provided
Not provided
Not provided
Evaluate if nocturnal hypoxemia is associated with post COVID-19 long term fatigue
| 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 | 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 | 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 | 6 - 7 months |
| Hospital de Faro (Chua) | Recruiting | Faro | 800-386 | Portugal |
|
| Hospital da Luz Guimaraes (HLG) | Recruiting | Guimarães | 4835-23 | Portugal |
|
| Hospital de Santo Andre (Chl) | Recruiting | Leiria | 2410-197 | Portugal |
|
| Hospital Da Luz Lisboa | Not yet recruiting | Lisbon | 1500-650 | Portugal |
|
| Hospital de Santa Maria (CHULN) | Recruiting | Lisbon | 1649-028 | Portugal |
|
| Hospital Beatriz Angelo (Hba) | Not yet recruiting | Loures | 2674-514 | Portugal |
|
| Hospital de Portimao (Chua) | Recruiting | Portimão | 8500-338 | Portugal |
|
| Hospital Sao Joao (Chusj) | Recruiting | Porto | 4200-319 | Portugal |
|
| Hospital de Sao Sebastiao (Chedv) | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
|
| Centro Hospitalar de Setubal (Chs) | Recruiting | Setúbal | 2910-549 | Portugal |
|
| Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD) | Recruiting | Vila Real | 5000-508 | Portugal |
|
| 32980614 | Background | Miller 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. |
| 33166287 | Background | Townsend 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. |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |