Long COVID-19 Fatigue and Obstructive Sleep Apnea

• Conditions: Long COVID; Obstructive Sleep Apnea of Adult; Fatigue
• Interventions: Other: OSA

• Registration Number: NCT05290350
• Lead Sponsor: Centro Hospitalar Universitario do Algarve

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).

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-10
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-22
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-11-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA Cohort	OSA	Patients With post COVID-19 condition and OSA

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (12)

Hospital de Faro (Chua); 🇵🇹 Faro, Portugal

Hospital Particular de Alvor; 🇵🇹 Alvor, Portugal

Hospital da Luz Guimaraes (HLG); 🇵🇹 Guimarães, Portugal

Hospital de Santo Andre (Chl); 🇵🇹 Leiria, Portugal

Hospital Sao Joao (Chusj); 🇵🇹 Porto, Portugal

Hospital de Sao Sebastiao (Chedv); 🇵🇹 Santa Maria Da Feira, Portugal

Hospital Da Luz Lisboa; 🇵🇹 Lisboa, Portugal

Hospital de Santa Maria (CHULN); 🇵🇹 Lisboa, Portugal

Hospital Beatriz Angelo (Hba); 🇵🇹 Loures, Portugal

Hospital de Portimao (Chua); 🇵🇹 Portimao, Portugal

Centro Hospitalar de Setubal (Chs); 🇵🇹 Setubal, Portugal

Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD); 🇵🇹 Vila Real, Portugal