Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-01 @ 7:33 AM
Study NCT ID:
NCT04775966
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2021-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8477}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)', 'timeFrame': '2020 versus 2019'}], 'secondaryOutcomes': [{'measure': 'Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)', 'timeFrame': '2020 versus 2019'}, {'measure': 'Change in PAP-adherence 2020 versus 2019 (h/days/weeks)', 'timeFrame': '2020 versus 2019'}, {'measure': 'Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)', 'timeFrame': '2020 versus 2019'}, {'measure': 'Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)', 'timeFrame': '2020 versus 2019'}, {'measure': 'Change in patient adherence 2020 versus 2019 (%).', 'timeFrame': '2020 versus 2019'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Apnea', 'Positive Airway Pressure', 'telemedicine', 'COVID 19'], 'conditions': ['Sleep Apnea Syndromes']}, 'referencesModule': {'references': [{'pmid': '35246109', 'type': 'RESULT', 'citation': 'Bertelli F, Suehs CM, Mallet JP, Court-Fortune I, Gagnadoux F, Borel JC, Gaubert O, Molinari N, Bourdin A, Jaffuel D. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea. Respir Res. 2022 Mar 4;23(1):46. doi: 10.1186/s12931-022-01969-z.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.', 'detailedDescription': 'The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the Adene group database treated with positive airway pressure (PAP) for sleep apnea in 2019 and 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient treated/monitored by the Adene group\n* treated for sleep apnea syndrome (i.e., an initial apnoea hypopnea index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/respiratory comorbidities) associated with symptoms from among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep, daytime tiredness)\n* Positive airway pressure (PAP)-treated for at least 4 months before January 1, 2019\n* continuous PAP during 2019\n* continuous PAP during 2020\n* acceptance of PAP telemonitoring with consent given for data collection and data anonymization\n\nExclusion Criteria:\n\n* less than 360 daily PAP tele-monitored data per year for 2019\n* less than 360 daily PAP tele-monitored data per year for 2020'}, 'identificationModule': {'nctId': 'NCT04775966', 'acronym': 'COVADENE', 'briefTitle': 'CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic', 'orgStudyIdInfo': {'id': 'RECHMPL21_0067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'Patients meeting eligibility criteria (see appropriate section).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Adene Group', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Dany Jaffuel, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Montpellier University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}