Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
300 participants
OBSERVATIONAL
2022-03-10
2023-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome
NCT02043483
SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study
NCT06711159
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
NCT01635010
Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment
NCT01976052
Acoustic OSA Prediction During Wakefulness and Monitoring During Sleep
NCT04112927
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OSA Cohort
Patients With post COVID-19 condition and OSA
OSA
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA
Control Cohort
Patients With post COVID-19 condition without OSA
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OSA
EXPOSURE TO OBSTRUCTIVE SLEEP APNEA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sociedade Portuguesa de Pneumologia
OTHER
Universidade do Algarve
OTHER
Universidade do Porto
OTHER
Center for Health Technology and Services Research
OTHER
Linde Health Care
OTHER
Centro Hospitalar Universitario do Algarve
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ligia Pires
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ligia Pires
Role: STUDY_CHAIR
Centro Hospitalar Universitario do Algarve
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Lisbon, , Portugal
Hospital de Santa Maria (CHULN)
Lisbon, , Portugal
Hospital Beatriz Angelo (Hba)
Loures, , Portugal
Hospital de Portimao (Chua)
Portimão, , Portugal
Hospital Sao Joao (Chusj)
Porto, , Portugal
Hospital de Sao Sebastiao (Chedv)
Santa Maria da Feira, , Portugal
Centro Hospitalar de Setubal (Chs)
Setúbal, , Portugal
Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)
Vila Real, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Johns 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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
132/21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.