Clinical trial NCT05290350: Long COVID-19 Fatigue and Obstructive Sleep Apnea
Official title: Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long COVID
Fatigue
Obstructive Sleep Apnea of Adult
Keywords: Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines
Lead sponsor: Centro Hospitalar Universitario do Algarve
Sponsor class: OTHER
Collaborators: name: Sociedade Portuguesa de Pneumologia
name: Universidade do Algarve
name: Universidade do Porto
name: Center for Health Technology and Services Research
name: Linde Health Care
First posted: 2022-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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).

Eligibility criteria: 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

Primary outcomes:
measure: post-COVID-19 long term fatigue and OSA
timeFrame: 6 - 7 months
Secondary outcomes:
measure: post-COVID-19 long term fatigue and daytime sleepiness
timeFrame: 6 - 9 months
measure: post-COVID-19 long term fatigue and nocturnal hypoxemia
timeFrame: 6 - 7 months
measure: post-COVID-19 long term fatigue and severity of acute COVID-19
timeFrame: 6 - 9 months
measure: post-COVID-19 long term fatigue and vaccination status
timeFrame: 6 - 9 months
measure: Long COVID-19 and OSA impact in quality of life
timeFrame: 6 - 7 months
Other outcomes:
Locations:
city: Alvor
country: Portugal
facility: Hospital Particular de Alvor
city: Faro
country: Portugal
facility: Hospital de Faro (Chua)
city: Guimarães
country: Portugal
facility: Hospital da Luz Guimaraes (HLG)
city: Leiria
country: Portugal
facility: Hospital de Santo Andre (Chl)
city: Lisboa
country: Portugal
facility: Hospital Da Luz Lisboa
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria (CHULN)
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo (Hba)
city: Portimao
country: Portugal
facility: Hospital de Portimao (Chua)
city: Porto
country: Portugal
facility: Hospital Sao Joao (Chusj)
city: Santa Maria Da Feira
country: Portugal
facility: Hospital de Sao Sebastiao (Chedv)
city: Setubal
country: Portugal
facility: Centro Hospitalar de Setubal (Chs)
city: Vila Real
country: Portugal
facility: Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)
Study officials:
affiliation: Centro Hospitalar Universitario do Algarve
name: Ligia Pires
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.