Long COVID-19 Fatigue and Obstructive Sleep Apnea

Last updated: March 26, 2022
Sponsor: Centro Hospitalar Universitario do Algarve
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Covid-19

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05290350
132/21
  • Ages 18-90
  • All Genders

Study Summary

Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease

Eligibility Criteria

Inclusion

Inclusion Criteria:

(1) ≥18 years; (2) previous COVID-19 at least six months before the initial study protocolevaluation; (3) persistent symptoms after cure criteria defined by WHO; (4) patients whoattend the post-COVID-19 follow-up consultation of the study centers. (5) SARS-CoV-2infection confirmed by a positive real-time reverse-transcription polymerase chain reactionon a nasopharyngeal swab (6) patients who agree to sign the Written informed consent (following the ethics committee protocol).

Exclusion

Exclusion Criteria:

(1) patients who had a concomitant neurological disorder that could increase OSA risk (suchas stroke, Parkinson disease, or amyotrophic lateral sclerosis); (2) patients who were oninvasive mechanical ventilation. (3) patients with persistent fatigue symptoms,6 monthsbefore SARS-CoV-2 infection (4) patients without SARS-CoV-2 positive real-timereverse-transcription polymerase chain reaction on a nasopharyngeal swab

Study Design

Total Participants: 300
Study Start date:
March 10, 2022
Estimated Completion Date:
January 30, 2023

Study 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).

Connect with a study center

  • Hospital Particular de Alvor

    Alvor, 8500-322
    Portugal

    Active - Recruiting

  • Hospital de Faro (Chua)

    Faro, 800-386
    Portugal

    Active - Recruiting

  • Hospital da Luz Guimaraes (HLG)

    Guimarães, 4835-23
    Portugal

    Active - Recruiting

  • Hospital de Santo Andre (Chl)

    Leiria, 2410-197
    Portugal

    Active - Recruiting

  • Hospital Da Luz Lisboa

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Hospital de Santa Maria (CHULN)

    Lisboa, 1649-028
    Portugal

    Active - Recruiting

  • Hospital Beatriz Angelo (Hba)

    Loures, 2674-514
    Portugal

    Site Not Available

  • Hospital de Portimao (Chua)

    Portimao, 8500-338
    Portugal

    Active - Recruiting

  • Hospital Sao Joao (Chusj)

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Hospital de Sao Sebastiao (Chedv)

    Santa Maria Da Feira, 4520-211
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Setubal (Chs)

    Setubal, 2910-549
    Portugal

    Active - Recruiting

  • Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)

    Vila Real, 5000-508
    Portugal

    Active - Recruiting

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