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Long COVID-19 Fatigue and Obstructive Sleep Apnea

Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05290350
Acronym
PostCoV2OSA
Enrollment
300
Registered
2022-03-22
Start date
2022-03-10
Completion date
2023-01-30
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Long COVID, Obstructive Sleep Apnea of Adult

Keywords

Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines

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).

Interventions

OTHEROSA

EXPOSURE TO OBSTRUCTIVE SLEEP APNEA

Sponsors

Sociedade Portuguesa de Pneumologia
CollaboratorOTHER
Universidade do Algarve
CollaboratorOTHER
Universidade do Porto
CollaboratorOTHER
Center for Health Technology and Services Research
CollaboratorOTHER
Linde Health Care
CollaboratorOTHER
Centro Hospitalar Universitario do Algarve
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
post-COVID-19 long term fatigue and OSA6 - 7 monthsEvaluate if untreated OSA is associated with post COVID-19 long term fatigue.

Secondary

MeasureTime frameDescription
post-COVID-19 long term fatigue and daytime sleepiness6 - 9 monthsEvaluate if daytime sleepiness is associated with post COVID-19 long term fatigue.
post-COVID-19 long term fatigue and nocturnal hypoxemia6 - 7 monthsEvaluate if nocturnal hypoxemia is associated with post COVID-19 long term fatigue
post-COVID-19 long term fatigue and severity of acute COVID-196 - 9 monthsEvaluate if severity of acute COVID-19 is associated with post COVID-19 long term fatigue
post-COVID-19 long term fatigue and vaccination status6 - 9 monthsStudy the relation between vaccination status and post-COVID-19 long term fatigue
Long COVID-19 and OSA impact in quality of life6 - 7 monthsStudy the impact of Long COVID-19 with untreated OSA in quality of life

Countries

Portugal

Contacts

Primary ContactLigia Pires
alves1029@hotmail.com+351282450300
Backup ContactTania Fatal
taniafatal@hotmail.com+351282450300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026