Long COVID-19 Fatigue and Obstructive Sleep Apnea (PostCoV2OSA)

March 26, 2022 updated by: Ligia Pires, Centro Hospitalar Universitario do Algarve

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Alvor, Portugal, 8500-322
        • Recruiting
        • Hospital Particular de Alvor
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Armin Bidarian, Prof
      • Faro, Portugal, 800-386
        • Recruiting
        • Hospital de Faro (CHUA)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karl Cunha, MD
        • Sub-Investigator:
          • Helena Ramos, MD
      • Guimarães, Portugal, 4835-23
        • Recruiting
        • Hospital da Luz Guimaraes (HLG)
        • Contact:
        • Principal Investigator:
          • Maria Jose Guimaraes
      • Leiria, Portugal, 2410-197
      • Lisboa, Portugal, 1500-650
        • Not yet recruiting
        • Hospital da Luz Lisboa
        • Contact:
        • Principal Investigator:
          • Sofia Furtado, MD
      • Lisboa, Portugal, 1649-028
        • Recruiting
        • Hospital de Santa Maria (CHULN)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Pinto, Prof
      • Loures, Portugal, 2674-514
      • Portimao, Portugal, 8500-338
        • Recruiting
        • Hospital de Portimâo (CHUA)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ines Simoes, MD
        • Sub-Investigator:
          • Catia Saraiva, MD
        • Sub-Investigator:
          • Ines Belchior, MD
        • Sub-Investigator:
          • Tania Fatal, MD
        • Sub-Investigator:
          • Catarina Possacos, MD
      • Porto, Portugal, 4200-319
        • Recruiting
        • Hospital Sao Joao (Chusj)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Drummond, Prof
        • Sub-Investigator:
          • Margarida Tavares, Prof
      • Santa Maria Da Feira, Portugal, 4520-211
        • Recruiting
        • Hospital de Sao Sebastiao (Chedv)
      • Setubal, Portugal, 2910-549
      • Vila Real, Portugal, 5000-508
        • Recruiting
        • Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)
        • Contact:
        • Principal Investigator:
          • Bebiana Conde, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted in twelve Portuguese Hospitals, Universitary and District, in which a follow-up post-COVID-19 medical consultation has been implemented All patients that attend the follow-up post COVID-19 consultation will be invited to participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSA Cohort
Patients With post COVID-19 condition and OSA
Other: OSA
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA
Control Cohort
Patients With post COVID-19 condition without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-COVID-19 long term fatigue and OSA
Time Frame: 6 - 7 months
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
Time Frame: 6 - 9 months
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
Time Frame: 6 - 7 months
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
Time Frame: 6 - 9 months
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
Time Frame: 6 - 9 months
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
Time Frame: 6 - 7 months
Study the impact of Long COVID-19 with untreated OSA in quality of life
6 - 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Universitario do Algarve

Collaborators

Universidade do Porto
Center for Health Technology and Services Research
Universidade do Algarve
Linde Health Care
Sociedade Portuguesa de Pneumologia

Investigators

  • Study Chair: Ligia Pires, Centro Hospitalar Universitario do Algarve

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2022

Primary Completion (ANTICIPATED)

November 30, 2022

Study Completion (ANTICIPATED)

January 30, 2023

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 26, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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