Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-22 @ 2:45 PM
Study NCT ID:
NCT05290350
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2022-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long COVID-19 Fatigue and Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-26', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-19', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-COVID-19 long term fatigue and OSA', 'timeFrame': '6 - 7 months', 'description': 'Evaluate if untreated OSA is associated with post COVID-19 long term fatigue.'}], 'secondaryOutcomes': [{'measure': 'post-COVID-19 long term fatigue and daytime sleepiness', 'timeFrame': '6 - 9 months', 'description': 'Evaluate if daytime sleepiness is associated with post COVID-19 long term fatigue.'}, {'measure': 'post-COVID-19 long term fatigue and nocturnal hypoxemia', 'timeFrame': '6 - 7 months', 'description': 'Evaluate if nocturnal hypoxemia is associated with post COVID-19 long term fatigue'}, {'measure': 'post-COVID-19 long term fatigue and severity of acute COVID-19', 'timeFrame': '6 - 9 months', 'description': 'Evaluate if severity of acute COVID-19 is associated with post COVID-19 long term fatigue'}, {'measure': 'post-COVID-19 long term fatigue and vaccination status', 'timeFrame': '6 - 9 months', 'description': 'Study the relation between vaccination status and post-COVID-19 long term fatigue'}, {'measure': 'Long COVID-19 and OSA impact in quality of life', 'timeFrame': '6 - 7 months', 'description': 'Study the impact of Long COVID-19 with untreated OSA in quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-COVID-19 fatigue Sleep Apnea SARS-CoV-2 Vaccines'], 'conditions': ['Long COVID', 'Fatigue', 'Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '8463991', 'type': 'BACKGROUND', 'citation': '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': '1798888', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32980614', 'type': 'BACKGROUND', '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.'}, {'pmid': '33166287', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': 'Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease', 'detailedDescription': "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).\n\nThere 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).\n\nIn 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.\n\nData 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).\n\nDemographic, 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).\n\nFatigue will be assessed using the Chalder fatigue scale - CFQ-11 (Chalter et al., 1993).\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(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).\n\nExclusion Criteria:\n\n(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'}, 'identificationModule': {'nctId': 'NCT05290350', 'acronym': 'PostCoV2OSA', 'briefTitle': 'Long COVID-19 Fatigue and Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar Universitario do Algarve'}, 'officialTitle': 'Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study', 'orgStudyIdInfo': {'id': '132/21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA Cohort', 'description': 'Patients With post COVID-19 condition and OSA', 'interventionNames': ['Other: OSA']}, {'label': 'Control Cohort', 'description': 'Patients With post COVID-19 condition without OSA'}], 'interventions': [{'name': 'OSA', 'type': 'OTHER', 'description': 'EXPOSURE TO OBSTRUCTIVE SLEEP APNEA', 'armGroupLabels': ['OSA Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500-322', 'city': 'Alvor', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ana Fontes, Prof', 'role': 'CONTACT', 'email': 'anafontes@grupohpa.com', 'phone': '282420400', 'phoneExt': '775'}, {'name': 'Ligia Pires, MD', 'role': 'CONTACT', 'email': 'ligiapires@grupohpa.com', 'phone': '282420400', 'phoneExt': '120'}, {'name': 'Ligia Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Armin Bidarian, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Particular de Alvor', 'geoPoint': {'lat': 37.12994, 'lon': -8.59174}}, {'zip': '800-386', 'city': 'Faro', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Karl Cunha, MD', 'role': 'CONTACT', 'email': 'karljonathan@gmail.com', 'phone': '289891100'}, {'name': 'Helena Ramos, MD', 'role': 'CONTACT', 'email': 'helena.chaves.ramos@hotmail.com', 'phone': '289891100'}, {'name': 'Karl Cunha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Helena Ramos, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Faro (Chua)', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'zip': '4835-23', 'city': 'Guimarães', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Maria Jose Guimaraes, MD', 'role': 'CONTACT', 'email': 'zezaguimaraes@gmail.com', 'phone': '+351253420300', 'phoneExt': '41053'}, {'name': 'Maria Jose Guimaraes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital da Luz Guimaraes (HLG)', 'geoPoint': {'lat': 41.44443, 'lon': -8.29619}}, {'zip': '2410-197', 'city': 'Leiria', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Joao Machado, MD', 'role': 'CONTACT', 'email': 'joaoneivamachado@gmail.com', 'phone': '+351 244 817 056', 'phoneExt': '3601'}, {'name': 'SALVATO FEIJO, MD', 'role': 'CONTACT', 'email': 'sec.pneumologia@chleiria.min-saude.pt', 'phone': '+351 244 817 055', 'phoneExt': '5811'}, {'name': 'Joao Machado, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Santo Andre (Chl)', 'geoPoint': {'lat': 39.74362, 'lon': -8.80705}}, {'zip': '1500-650', 'city': 'Lisbon', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Sofia Furtado, MD', 'role': 'CONTACT', 'email': 'sfurtado@hospitaldaluz.pt', 'phone': '21 710 4400'}, {'name': 'Sofia Furtado, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Da Luz Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-028', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Paula Pinto, Prof', 'role': 'CONTACT', 'email': 'paulagpinto@gmail.com', 'phone': '217805000', 'phoneExt': '55395'}, {'name': 'Cristina Barbara, Prof', 'role': 'CONTACT', 'email': 'pndr@dgs.min-saude.pt', 'phone': '218430500'}, {'name': 'Paula Pinto, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Santa Maria (CHULN)', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '2674-514', 'city': 'Loures', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Vera Martins, MD', 'role': 'CONTACT', 'email': 'vera.martins2@hba.min-saude.pt', 'phone': '+351 219 847 240'}, {'name': 'Margarida Barata, MD', 'role': 'CONTACT', 'email': 'margarida.duarte.barata@hba.min-saude.pt', 'phone': '+351 219 847 240'}, {'name': 'Vera Martins', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Margarida Barata', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Beatriz Angelo (Hba)', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}, {'zip': '8500-338', 'city': 'Portimão', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ligia Pires, MD', 'role': 'CONTACT', 'email': 'alves1029@hotmail.com', 'phone': '282450300', 'phoneExt': '43178'}, {'name': 'Tania Fatal', 'role': 'CONTACT', 'email': 'taniafatal@hotmail.com', 'phone': '282450300', 'phoneExt': '35427'}, {'name': 'Ligia Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ines Simoes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catia Saraiva, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ines Belchior, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tania Fatal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catarina Possacos, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Portimao (Chua)', 'geoPoint': {'lat': 37.13856, 'lon': -8.53775}}, {'zip': '4200-319', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Marta Drummond, Prof', 'role': 'CONTACT', 'email': 'marta.drummond@gmail.com', 'phone': '+351225512100'}, {'name': 'Renato Silva', 'role': 'CONTACT', 'email': 'renato.ivos@gmail.com', 'phone': '+351225513600'}, {'name': 'Marta Drummond, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Margarida Tavares, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Sao Joao (Chusj)', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4520-211', 'city': 'Santa Maria da Feira', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ana Sofia Barroso, MD', 'role': 'CONTACT', 'email': 'anasofiabarroso@gmail.com', 'phone': '+351 256 379 700'}, {'name': 'Jorge Ferreira, Prof', 'role': 'CONTACT', 'email': 'pneumologia@chedv.min-saude.pt', 'phone': '+351 256 379 700'}, {'name': 'Ana Sofia Barroso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jorge Ferreira, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Sao Sebastiao (Chedv)', 'geoPoint': {'lat': 40.92726, 'lon': -8.54839}}, {'zip': '2910-549', 'city': 'Setúbal', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Vera Clerigo, MD', 'role': 'CONTACT', 'email': 'vera.clerigo@chs-min-saude.pt', 'phone': '265 549 085'}, {'name': 'Paula Duarte, MD', 'role': 'CONTACT', 'email': 'secpneumologia@chs.min-saude.pt', 'phone': '265 549 000'}, {'name': 'Vera Clerigo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Hospitalar de Setubal (Chs)', 'geoPoint': {'lat': 38.5244, 'lon': -8.8882}}, {'zip': '5000-508', 'city': 'Vila Real', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Bebiana Conde, Prof', 'role': 'CONTACT', 'email': 'bebianaconde@gmail.com', 'phone': '259300500', 'phoneExt': '4480'}, {'name': 'Bebiana Conde, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Hospitalar De Trás-Os-Montes E Alto Douro (CHTMAD)', 'geoPoint': {'lat': 41.3001, 'lon': -7.7432}}], 'centralContacts': [{'name': 'Ligia Pires', 'role': 'CONTACT', 'email': 'alves1029@hotmail.com', 'phone': '+351282450300', 'phoneExt': '43168'}, {'name': 'Tania Fatal', 'role': 'CONTACT', 'email': 'taniafatal@hotmail.com', 'phone': '+351282450300', 'phoneExt': '35427'}], 'overallOfficials': [{'name': 'Ligia Pires', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro Hospitalar Universitario do Algarve'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar Universitario do Algarve', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedade Portuguesa de Pneumologia', 'class': 'OTHER'}, {'name': 'Universidade do Algarve', 'class': 'OTHER'}, {'name': 'Universidade do Porto', 'class': 'OTHER'}, {'name': 'Center for Health Technology and Services Research', 'class': 'OTHER'}, {'name': 'Linde Health Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ligia Pires', 'investigatorAffiliation': 'Centro Hospitalar Universitario do Algarve'}}}}