Long COVID-19 Fatigue and Obstructive Sleep Apnea

Fatigue Clinical Trial

— PostCoV2OSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290350
• Other study ID #: 132/21
• Status: Recruiting
• Start date: March 10, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2022
• Source: Centro Hospitalar Universitario do Algarve
• Contact: Ligia Pires
• Phone: +351282450300
• Email: alves1029[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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

Related Conditions & MeSH terms

• Apnea
• COVID-19
• Fatigue
• Long COVID
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• OSA
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA

Locations

Country	Name	City	State
Portugal	Hospital Particular de Alvor	Alvor
Portugal	Hospital de Faro (Chua)	Faro
Portugal	Hospital da Luz Guimaraes (HLG)	Guimarães
Portugal	Hospital de Santo Andre (Chl)	Leiria
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	Hospital Sao Joao (Chusj)	Porto
Portugal	Hospital de Sao Sebastiao (Chedv)	Santa Maria Da Feira
Portugal	Centro Hospitalar de Setubal (Chs)	Setubal
Portugal	Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)	Vila Real

Sponsors (6)

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

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. — View Citation

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. — View Citation

Miller MA, Cappuccio FP. A systematic review of COVID-19 and obstructive sleep apnoea. Sleep Med Rev. 2021 Feb;55:101382. doi: 10.1016/j.smrv.2020.101382. Epub 2020 Sep 8. — View Citation

Townsend L, Dyer AH, Jones K, Dunne J, Mooney A, Gaffney F, O'Connor L, Leavy D, O'Brien K, Dowds J, Sugrue JA, Hopkins D, Martin-Loeches I, Ni Cheallaigh C, Nadarajan P, McLaughlin AM, Bourke NM, Bergin C, O'Farrelly C, Bannan C, Conlon N. Persistent fatigue following SARS-CoV-2 infection is common and independent of severity of initial infection. PLoS One. 2020 Nov 9;15(11):e0240784. doi: 10.1371/journal.pone.0240784. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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