Fatigue, Long COVID, Obstructive Sleep Apnea of Adult
Conditions
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
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| post-COVID-19 long term fatigue and OSA | 6 - 7 months | Evaluate if untreated OSA is associated with post COVID-19 long term fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-COVID-19 long term fatigue and daytime sleepiness | 6 - 9 months | Evaluate if daytime sleepiness is associated with post COVID-19 long term fatigue. |
| post-COVID-19 long term fatigue and nocturnal hypoxemia | 6 - 7 months | Evaluate if nocturnal hypoxemia is associated with post COVID-19 long term fatigue |
| post-COVID-19 long term fatigue and severity of acute COVID-19 | 6 - 9 months | Evaluate if severity of acute COVID-19 is associated with post COVID-19 long term fatigue |
| post-COVID-19 long term fatigue and vaccination status | 6 - 9 months | Study the relation between vaccination status and post-COVID-19 long term fatigue |
| Long COVID-19 and OSA impact in quality of life | 6 - 7 months | Study the impact of Long COVID-19 with untreated OSA in quality of life |
Countries
Portugal