Long COVID-19 Fatigue and Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Long COVID, Fatigue, Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Other: OSA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA Cohort<br>Patients With post COVID-19 condition and OSA | Other: OSA<br>* EXPOSURE TO OBSTRUCTIVE SLEEP APNEA<br>|
| Control Cohort<br>Patients With post COVID-19 condition without OSA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines