Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study
| Autor: | Naïma Zarqane, Isabelle Godard, Georgios Papaioannou, Jean-Louis Pépin, Jean Claude Deharo, Frédéric Roche, Nicolas Molinari, Philippe Gosse, Frédéric Gagnadoux, Vincent Puel, Fabrice Thoin, Carey M. Suehs |
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| Přispěvatelé: | Nouvelle Clinique Bel-Air [Bordeaux] (NCBA), CHU Bordeaux [Bordeaux], Centre Hospitalier Universitaire [Grenoble] (CHU), Clinique Bouchard - ELSAN [Marseille], Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Département de Cardiologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre Hospitalier Princesse Grace de Monaco (CHPG), Monaco, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Guieu, régis, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
adult thoracic medicine
medicine.medical_specialty [SDV]Life Sciences [q-bio] Population Pilot Projects Polysomnography 030204 cardiovascular system & hematology Sleep medicine VALIDATION Cohort Studies 03 medical and health sciences 0302 clinical medicine Sleep Apnea Syndromes Quality of life [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system QUALITY-OF-LIFE adult cardiology medicine Palpitations Syncope Vasovagal Humans 030212 general & internal medicine education RECURRENCE Vasovagal syncope Respiratory Medicine Presyncope education.field_of_study [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology medicine.diagnostic_test business.industry sleep medicine General Medicine medicine.disease 3. Good health [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system [SDV] Life Sciences [q-bio] DAYTIME SLEEPINESS Physical therapy Medicine France medicine.symptom business [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology Cohort study |
| Zdroj: | BMJ Open BMJ Open, 2020, 10 (9), pp.e038791. ⟨10.1136/bmjopen-2020-038791⟩ BMJ Open, Vol 10, Iss 9 (2020) BMJ Open, BMJ Publishing Group, 2020, 10 (9), pp.e038791. ⟨10.1136/bmjopen-2020-038791⟩ |
| ISSN: | 2044-6055 |
| Popis: | IntroductionRecurrent vasovagal syncope (VVS) is associated with decreased quality-of-life and frequent use of emergency services. The evidence base for causality, diagnostic procedures and potential VVS treatments is poor. Scattered observations in the literature suggest a link between respiratory disturbances during sleep and VVS. Empirical observations lead us to further hypothesise that the appropriate management of sleep apnoea syndrome (SAS) may help resolve comorbid recurrent VVS in certain patients. We therefore designed this pilot study to provide a framework for the observation of changes in outcomes accompanying the deployment of SAS treatments in patients with VVS.Methods and analysisThis is a multicentre, registry-based study whose primary objective is to evaluate the effect of SAS management on the number of syncope/presyncope episodes in a population suffering from both VVS and SAS. To this effect, syncope rates prior to the treatment of SAS will be compared with those occurring after the initiation of the latter. In addition, yearly assessments will collect data for echocardiography, polysomnography, Holter monitoring, table tilt tests, multiple sleep latency tests, SAS management parameters and questionnaires describing fatigue, depression and quality-of-life. Sixty patients will be included with a minimum follow-up period of 12 months. The primary analysis will use comparisons of centrality for paired data to describe the changes in syncope rates before versus after the initiation of SAS management. Longitudinal data will be analysed using mixed models with patients set as a random effect. Subgroup analyses will be performed for SAS-treatment adherence and efficacy.Ethics and disseminationThe VVS-SAS registry was approved by an ethics committee (Comité pour la Protection des Personnes Ile-de-France VI, Reference number CPP/2-18) in accordance with French law. The princeps publication will present before–after SAS management results and longitudinal analyses.Trial registration numberNCT04294524. Pre-results. |
| Databáze: | OpenAIRE |
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