Long COVID-19 Fatigue and Obstructive Sleep Apnea
PostCoV2OSA
Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study
1 other identifier
observational
300
1 country
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedFirst Submitted
Initial submission to the registry
March 19, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedApril 6, 2022
March 1, 2022
9 months
March 19, 2022
March 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
post-COVID-19 long term fatigue and daytime sleepiness
6 - 9 months
post-COVID-19 long term fatigue and nocturnal hypoxemia
6 - 7 months
post-COVID-19 long term fatigue and severity of acute COVID-19
6 - 9 months
post-COVID-19 long term fatigue and vaccination status
6 - 9 months
Long COVID-19 and OSA impact in quality of life
6 - 7 months
Study Arms (2)
OSA Cohort
Patients With post COVID-19 condition and OSA
Control Cohort
Patients With post COVID-19 condition without OSA
Interventions
Eligibility Criteria
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.
You may qualify if:
- (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).
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro Hospitalar Universitario do Algarvelead
- Sociedade Portuguesa de Pneumologiacollaborator
- Universidade do Algarvecollaborator
- Universidade do Portocollaborator
- Center for Health Technology and Services Researchcollaborator
- Linde Health Carecollaborator
Study Sites (12)
Hospital Particular de Alvor
Alvor, 8500-322, Portugal
Hospital de Faro (Chua)
Faro, 800-386, Portugal
Hospital da Luz Guimaraes (HLG)
Guimarães, 4835-23, Portugal
Hospital de Santo Andre (Chl)
Leiria, 2410-197, Portugal
Hospital Da Luz Lisboa
Lisbon, 1500-650, Portugal
Hospital de Santa Maria (CHULN)
Lisbon, 1649-028, Portugal
Hospital Beatriz Angelo (Hba)
Loures, 2674-514, Portugal
Hospital de Portimao (Chua)
Portimão, 8500-338, Portugal
Hospital Sao Joao (Chusj)
Porto, 4200-319, Portugal
Hospital de Sao Sebastiao (Chedv)
Santa Maria da Feira, 4520-211, Portugal
Centro Hospitalar de Setubal (Chs)
Setúbal, 2910-549, Portugal
Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)
Vila Real, 5000-508, Portugal
Related 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. doi: 10.1016/0022-3999(93)90081-p.
PMID: 8463991BACKGROUNDJohns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PMID: 1798888BACKGROUNDMiller 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.
PMID: 32980614BACKGROUNDTownsend 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.
PMID: 33166287BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ligia Pires
Centro Hospitalar Universitario do Algarve
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2022
First Posted
March 22, 2022
Study Start
March 10, 2022
Primary Completion
November 30, 2022
Study Completion
January 30, 2023
Last Updated
April 6, 2022
Record last verified: 2022-03