Sleep Apnea Network / European Sleep Apnea Database (ESADA)
The ESADA study was started as a joint project within the European Union COST action B26 network of nationally appointed sleep apnea experts in 2007. Up to January 2021, there are 39 contributing and 29 actively recruiting centers across Europe and data from in excess of 34.000 patients with close to 55.000 visits have been entered so far. Current and past ESADA collaborators are listed below. Since 2016, the ESADA has been supported from the European Respiratory Society (ERS) through Clinical Research Collaboration (CRC) grants.
The ESADA serves as a reference database on European sleep apnea patients and current research is focused on the identification of specific sleep apnea phenotypes and longitudinal treatment outcomes. Thirty scientific communications based on the data assembled by the ESADA network have been published so far (see listing below). The ESADA also serves as a bridge for education and knowledge transfer between the various participating centers. There are ongoing efforts to generate collaborative ties between ESADA and other large European databases in sleep apnea research. The ESADA is a strong partner with 24 participating centers in the EU funded SLEEP REVOLUTION project.
The aims of the European Sleep Apnea Database project are to:
- Build the largest existing database of patients with sleep and breathing disorders
- Collect patient information from a network of European sleep centers
- Execute cross-sectional, prespective, interventional or long-term follow-up studies based on information in the data base.
Patients recruited in the ESADA have been referred to a sleep center due to suspected obstructive sleep apnea (OSA). Enrolment is consecutive and the inclusion criteria enable essentially all new untreated patients independent of comorbidity, concomitant medication and degree of sleepiness.
A unique feature of the ESADA is a specifically designed web-based data collection format constructed for transfer of data to a central database located and coordinated at the Gothenburg University. A uniform clinical report format (CRF) module containing some 8 pages is used for registration of clinical data including anthropometrics, medical history, sleep data, clinical symptoms, limited clinical chemistry and medication. Recruited patients will generate a base cohort representing the various participating European Sleep Centres.
All patients referred to the participating laboratories are considered for inclusion into the cohort. Data from patients fulfilling all inclusion criteria are consecutively transferred to the centralized data base by use of a web based clinical report format (CRF) module.
A patient included into the data base is labelled only by a unique patient identification number. A detailed patient identification log is established at each study site. Blood samples for a future joint genetic analysis are kept under coded conditions at the discretion of each participating center. The CRF uses predefined modules in order to enable repeated entries into the data base for registration of consecutive follow up data, gathered according to local clinical routines. The ESADA also enables new and specific CRF modules for specific substudy (eg. specific patient groups, interventional trials, health economy evaluations) that may be initiated by initiatives between various centers within the network. These specific CRF modules are only accessible by those centres opting to participate in a specific substudy protocol
ESADA has appointed study monitors in order to provide education and instructions related to completion of the CRF modules. The monitors are responsible for continuous quality assurance of data entered into the data base and provide feed back to centres not complying with the minimal standard of study data entry. The initial term of the monitors is at least one year and has included at least one initiating site visit at each of the participating centres. Data are collectively owned by all participating and contributing centres. A joint study group consisting of 2 appointed representatives from each centre constitute the board of the foundation. Additional adjunct members from the different centres, without the right to vote at the board meeting, may be appointed by the board pending the specific research issues to be addressed. The ESADA network has received support from the COST action B26 and seeding grants from the CPAP industry for establishment of the organisation and the data base. The intention is to seek further economical support for the maintenece and expansion of the cohort from the European Framework Program (FP7).
The first cross sectional analysis was planned at approximately 3,500 patients and a final recruitment goal is set at 7,000 patients with sleep disordered breathing. Beside the scientific opportunities offered, the ESADA will generate possibilities to achieve local and cross national sleep laboratory standardization within the EU, improvement of quality of care as well as increased scientific and clinical exchange of ideas and practices between different European sleep centers.
Specific study targets and objectives
The overall objective is to generate a database useful for multiple scientific protocols
1. Primary objective:
- to generate cross sectional data on anthropometrics, sleepiness measures and comorbidity in European patients with various degree of OSA severity.
2. Secondary objectives:
- to measure the incidence of cardiovascular disease (hypertension, stroke, ischemic heart disease).
- to prospectively explore the cardiovascular and overall mortality in OSA and its relation to OSA severity and cardiovascular risk factors.
- to explore the effect of different OSA treatment modalities like CPAP, oral devices or surgery on hemodynamic and metabolic parameters (e.g. blood pressure, HbA1c, lipid status) as well as on cardiovascular morbidity, metabolic disorder and sleepiness.
3. Tertiary objectives:
- to explore the dose-response relationship between OSA severity and hypertension, hyperglycemia, cardiovascular morbidity, metabolic disorder and sleepiness.
- to assess the effect of age, gender, domicile as well as cardiovascular and metabolic comorbidity on cardiovascular endpoints in sleep apnea patients.
- to assess the value of various sleep laboratory procedures in terms of diagnostic and treatment routines on outcome in sleep apnea patients.
- to assess the safety, tolerability and compliance with long-term CPAP treatment, oral devices and surgery (safety and tolerability).
European sleep laboratory clinical process evaluation
- to assess the regional differences across sleep laboratories in Europe regarding patient populations, treatment allocations, diagnostic work up, as well as adherence to therapy.
- to transfer know-how and to unify procedures as well as to generate minimum standards between different European sleep laboratories by the use of a standardized data acquisition procedure.
- to generate a data base to be used for future health economical assessments in sleep apnea patients in relation to the various national health care systems.
Substudy protocols to be generated from the joint database
- to create a network of scientifically active sleep centres and a joint database to be used for specific patient recruitment in future collaborative studies (e.g. specific cardiovascular, metabolic, genetic and treatment protocols).
Publications of the ESADA Group
- M. Wächter, J.W. Kantelhardt, M.R. Bonsignore, I. Bouloukaki, P. Escourrou, I. Fietze, L. Grote, D. Korzybski, C. Lombardi, O. Marrone, I. Paranicova, A. Pataka, S. Ryan, S. Schiza, P. Sliwinski, P. Steiropoulos, J. Verbraecken, T. Penzel, ESADA Study Group. Unique sleep-stage transitions determined by obstructive sleep apnea severity, age and gender. J Sleep Research 2020 Apr;29(2):e12895.
- Grote L, McNicholas WT, Hedner J; ESADA collaborators. Sleep apnoea management in Europe during the COVID-19 pandemic: data from the European Sleep Apnoea Database (ESADA). Eur Respir J. 2020;55(6):2001323. Published 2020 Jun 18. doi:10.1183/13993003.01323-2020.
- Marrone O, Cibella F, Roisman G, et al. Effects of sleep apnea and kidney dysfunction on objective sleep quality in non-dialyzed patients with chronic kidney disease: an ESADA study. J Clin Sleep Med. 2020;10.5664/jcsm.8542.
- Bouloukaki I, Grote L, McNicholas WT, et al. Mild obstructive sleep apnea increases hypertension risk, challenging traditional severity classification. J Clin Sleep Med. 2020;16(6):889-898. doi:10.5664/jcsm.8354
- Gunduz C, Basoglu OK, Kvamme JA, Verbraecken J, Anttalainen U, Marrone O, Steiropoulos P, Roisman G, Joppa P, Hein H, Trakada G, Hedner J, Grote L. Long-term positive airway pressure therapy is associated with reduced total cholesterol levels in patients with obstructive sleep apnea: data from the European Sleep Apnea Database (ESADA.) Sleep Medicine 2020; 75: 201-209
- Svedmyr S, Hedner J, Zou D, Parati G, Ryan S, Hein H, Pepin JL, Tkacova R, Marrone O, Schiza S, Basoglu O, Grote L: Superior hypertension control with betablockade in the European Sleep Apnea Database. J Hypertension. 2020.
- Bailly S, Grote L, Hedner J, Schiza S, McNicholas WT, Basoglu OK, Lombardi C, Dogas Z, Roisman G, Pataka A, Bonsignore MR, Pepin JL: Clusters of sleep apnoea phenotypes: A European perspective study from the ESADA database. Respirology 2020
- Pengo M, Faini A, Grote L, Ludka L, Joppa P, Pataka A, Dogas Z, Mihaicuta S, Hein H, Anttalainen U, Ryan S, Lombardi C, and Parati G. Impact of sleep apnea on cardioembolic risk in patients with atrial fibrillation: data from the ESADA cohort. Stroke. 2020
- Riha R, Kotoulas SC, Pataka A, Kvamme JA, Joppa P, Hedner J. Obstructive Sleep Apnoea in adult atients post-tonsillectomy. Sleep Medicine
- W. Randerath, S. Herkenrath, M. Treml, L. Grote, J. Hedner, M. R. Bonsignore, J. L. Pépin, S. Ryan, S. Schiza, J. Verbraecken, W. T. McNicholas, A. Pataka, P. Sliwinski, OK Basoglu. Evaluation of a multicomponent grading system (Baveno classification) for obstructive sleep apnoea. ERJ Open. 2021, in press.
Publications of the COST Action B26
- Parati G, Lombardi C, Hedner J, Bonsignore MR, Grote L, Tkacova R, Lévy P, Riha R, Bassetti C, Narkiewicz K, Mancia G, McNicholas WT; EU COST Action B26 members. Recommendations for the management of patients with obstructive sleep apnoea and hypertension. Eur Respir J. 2013 Mar;41(3):523-38. doi: 10.1183/09031936.00226711. PubMed PMID: 23397300.
- Parati G, Lombardi C, Hedner J, Bonsignore MR, Grote L, Tkacova R, Levy P, Riha R, Bassetti C, Narkiewicz K, Mancia G, McNicholas WT; European Respiratory Society; EU COST ACTION B26 members. Position paper on the management of patients with obstructive sleep apnea and hypertension: joint recommendations by the European Society of Hypertension, by the European Respiratory Society and by the members of European COST (COoperation in Scientific and Technological research) ACTION B26 on obstructive sleep apnea. J Hypertens. 2012 Apr;30(4):633-46. doi: 10.1097/HJH.0b013e328350e53b. PubMed PMID: 22406463.
- Bonsignore MR, McNicholas WT, Montserrat JM, Eckel J. Adipose tissue inobesity and obstructive sleep apnoea. Eur Respir J. 2012 Mar;39(3):746-67. doi: 10.1183/09031936.00047010. Review. PubMed PMID: 21920888.
- Fietze I, Penzel T, Alonderis A, Barbe F, Bonsignore MR, Calverly P, De Backer W, Diefenbach K, Donic V, Eijsvogel MM, Franklin KA, Gislason T, Grote L, Hedner J, Jennum P, Lavie L, Lavie P, Levy P, Lombardi C, Mallin W, Marrone O,Montserrat JM, Papathanasiou ES, Parati G, Plywaczewski R, Pretl M, Riha RL, Rodenstein D, Saaresranta T, Schulz R, Sliwinski P, Steiropoulos P, Svaza J, Tomori Z, Tonnesen P, Varoneckas G, Verbraecken J, Vesely J, Vitols A, Zielinski J, McNicholas WT; COST Action B26 Group. Management of obstructive sleep apnea in Europe. Sleep Med. 2011 Feb;12(2):190-7. doi: 10.1016/j.sleep.2010.10.003.PubMed PMID: 21167776.
- Rodenstein D; Cost-B26 Action on Sleep Apnoea Syndrome. Driving in Europe: the need of a common policy for drivers with obstructive sleep apnoea syndrome. J Sleep Res. 2008 Sep;17(3):281-4. doi: 10.1111/j.1365-2869.2008.00669.x. Epub 2008 Jul 22. PubMed PMID: 18651866.
- Riha RL, Diefenbach K, Jennum P, McNicholas WT; Management Committee, COST B26 Action on Sleep Apnoea Syndrome. Genetic aspects of hypertension and metabolic disease in the obstructive sleep apnoea-hypopnoea syndrome. Sleep Med Rev. 2008 Feb;12(1):49-63. doi: 10.1016/j.smrv.2007.08.004. Review. PubMed PMID: 18201663.
- McNicholas WT, Bonsigore MR; Management Committee of EU COST ACTION B26. Sleep apnoea as an independent risk factor for cardiovascular disease: current evidence, basic mechanisms and research priorities. Eur Respir J. 2007 Jan;29(1):156-78. Review. Mar;29(3):614.PubMed PMID: 17197482.
Centers with start-up process
ENT department at Mainz University, Germany and Pulmonary Department, University Hospital, Istanbul, Turkey
Collaborators in the ESADA project
- Alexandroupolis, Greece
- Steiropoulos P, Sleep Unit, Department of Pneumonology, Democritus University of Thrace, Alexandroupolis, Greece
- Antwerp, Belgium
- Verbraecken J, Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium
- Petiet E, Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium
- Athens, Greece
- Georgia Trakada, Pulmonary Medicine, National and Kapodistrian University of Athens, Athens, Greece
- Barcelona, Spain (inactive)
- Montserrat JM, Hospital Clinic i Provincial de Barcelona, Barcelona, IDIBAPS Barcelona and CIBERes, Madrid, Spain
- Berlin, Germany
- Fietze I, Schlafmedizinisches Zentrum, Charité – Universitätsmedizin Berlin, Germany
- Penzel T, Schlafmedizinisches Zentrum, Charité – Universitätsmedizin Berlin, Germany
- Naima Laharnar, Schlafmedizinisches Zentrum, Charité – Universitätsmedizin Berlin, Germany
- Brno, Czech Republic
- Ondrej Ludka, Department of Internal Medicine, University Hospital Brno, Czech Republic
- Brussels, Belgium (inactive)
- Daniel Rodenstein, Cliniques Universitaires Saint-Luc (Brussels, Belgium)
- Caeceres, Spain (inactive)
- Masa JF, Hospital San Pedro de Alcàntara, Cáceres, Spain
- Crete, Greece
- Bouloukaki I. Sleep Disorders Unit, Department of Respiratory Medicine, Medical School, University of Crete, Greece
- Schiza S, Sleep Disorders Unit, Department of Respiratory Medicine, Medical School, University of Crete, Greece
- Dublin, Ireland
- Kent B, Guy’s and St Thomas’ NHS Foundation Trust , Guy’s Hospital, London, UK
- McNicholas WT, Department of Respiratory Medicine, St. Vincent´s University Hospital, Dublin, Ireland
- Ryan S, Pulmonary and SleepDisorders Unit, St. Vincent’sUniversityHospital, Dublin, Ireland
- Edinburgh, United Kingdom
- Riha RL, Department of Sleep Medicine, Royal Infirmary Edinburgh, Scotland
- Förde, Norway
- Kvamme JA, Sleep Laboratory, ENT Department, Førde Central Hospital, Førde, Norway
- Giessen, Germany (inactive)
- Schulz R, Sleep Disorders Centre, University of Giessen, Lung Centre, Giessen, Germany
- Gothenburg, Sweden
- Ding Zou, Sleep Disorders Center, Pulmonary Department, Sahlgrenska University Hospital, and Center of Sleep and Wake Disorders, Sahlgrenska Academy, Gothenburg University, Göteborg, Sweden
- Grote L, Sleep Disorders Center, Pulmonary Department, Sahlgrenska University Hospital, and Center of Sleep and Wake Disorders, Sahlgrenska Academy, Gothenburg University, Göteborg, Sweden
- Hedner J, Sleep Disorders Center, Pulmonary Department, Sahlgrenska University Hospital, and Center of Sleep and Wake Disorders, Sahlgrenska Academy, Gothenburg University, Göteborg, Sweden
- Grenoble, France
- Pépin JL, Université Grenoble Alpes, INSERM HP2 (U1042) and Grenoble University Hospital, Grenoble, France
- Levy P, Université Grenoble Alpes, INSERM HP2 (U1042) and Grenoble University Hospital, Grenoble, France
- Bailly S, Université Grenoble Alpes, INSERM HP2 (U1042) and Grenoble University Hospital, Grenoble, France
- Haifa, Israel (inactive)
- Lena Lavie and Peretz Lavie, Centre for Sleep Medicine, Technion Institute of Technology, Haifa, Israel
- Hamburg, Germany
- Hein H, Sleep Disorders Center, St. Adolf Stift, Reinbeck, Germany
- Izmir, Turkey
- Basoglu OK, Department of Chest Diseases, Ege University, Izmir, Turkey
- Tasbakan MS, Department of Chest Diseases, Ege University, Izmir, Turkey
- Klapeida, Lithuania (inactive)
- Varoneckas G, Institute Psychophysiology and Rehabilitation, Palanga, Lithuania
- Klecany, Czech Republic
- Buskova J, Department of Sleep Medicine, National Institute of Mental Health, Klecany, Czech Republic
- Kosice, Slovakia
- Joppa P, Department of Respiratory Medicine and Tuberculosis, Faculty of Medicine, P.J.Safarik University and L. Pasteur University Hospital, Kosice, Slovakia
- Tkacova R, Department of Respiratory Medicine and Tuberculosis, Faculty of Medicine, P.J.Safarik University and L. Pasteur University Hospital, Kosice, Slovakia
- Lisbon, Portugal
- Staats R, Department of Respiratory Medicine, Hospital de Santa Maria, Lisbon, Portugal
- Leuven, Belgium
- Dries Testelmans, Sleep Disorders Centre, University Hospital Gasthuisberg, Leuven, Belgium
- Lleida, Spain (inactive)
- Barbé F, Servei Pneumologia Hospital Arnau de Vilanova and Hospital Santa Maria, Lleida, and CIBERes, Madrid, Spain
25. Mainz, Germany
- Haralampos Gouveris, ENT department at Mainz University Hospital, Mainz, Germany
- Milano, Italy
- Lombardi C, Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular, Neural and Metabolic Sciences, St. Luke Hospital, Milan & Department of Medicine and Surgery; University of Milano-Bicocca, Milan, Italy.
- Parati G, Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular, Neural and Metabolic Sciences, St. Luke Hospital, Milan & Department of Medicine and Surgery; University of Milano-Bicocca, Milan, Italy.
- Palermo, Italy
- Bonsignore MR, PROMISE Dept., University of Palermo, Palermo, Italy
- Marrone O, CNR Istituto per la Ricerca e l’Innovazione Biomedica, Palermo, Italy
- Pavia, Italy
- Francesco Fanfulla, Unità Operativa di Medicina del Sonno, Istituto Scientifico di Pavia IRCCS, Pavia, Italy
- Paris, France
- Escourrou P, Service dÉxplorations Fonctionnelles Multidisciplinaires Hospital Antoine Beclere, Clamart, France
- Petitjean M, Unité de Médecine du Sommeil, Hopital Antoine-Beclere, Clamart, France
- Roisman G, Unité de Médecine du Sommeil, Hopital Antoine-Beclere, Clamart, France
- Porto, Portugal
- Marta Drummond, Pulmonology Department Hospital São João, Medicine Faculty of Porto University, Porto, Portugal
- Mafalda van Zeller, Pulmonology Department Hospital São João, Medicine Faculty of Porto University, Porto, Portugal
- Prague, Czech Republic (inactive)
- Pretl M,Centre for Sleep and Waking Disorders, Department of Neurology, First Faculty of Medicine, Charles University, Prague, and Inspamed, Neurology and Sleep Laboratory, Prague, Czech Republic
- Riga, Latvia (inactive)
- Vitols A, Institute of Cardiology, University of Latvia, Riga, Latvia
- Solingen, Germany
- Simon Herkenrath, Sleep Disorders Centre, Pulmonary Clinic, Solingen, Germany
- Winfried Randerath, Sleep Disorders Centre, Pulmonary Clinic, Solingen, Germany
- Split, Croatia
- Dogas Z, Sleep Medicine Center, Department of Neuroscience, University of Split School of Medicine, Split, Croatia
- Galic, T, Sleep Medicine Center, Department of Neuroscience, University of Split School of Medicine, Split, Croatia
- Thessaloniki, Greece
- Pataka A, Respiratory Failure Unit, G. Papanikolaou Hospital, Thessalonika, Greece
- Timisoara, Rumania
- Stefan Mihaicuta, Pulmonary Department, Victor Babes University of Medicine and Pharmacy, Victor Babes Hospital, Timisoara, Rumania
- Turku, Finland
- Anttalainen U, Division of Medicine, Department of Pulmonary Diseases, Turku University Hospital and Sleep Research Centre, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Finland
- Saaresranta T, Division of Medicine, Department of Pulmonary Diseases, Turku University Hospital and Sleep Research Centre, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Finland
- 38. Institute of Tuberculosis and Lung Diseases
Sliwinski P, 2nd Department of Respiratory Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
- Plywaczewski R, 2nd Department of Respiratory Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
- Medical University of Warzaw (inactive)
- Bielicki P, Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw, Warsaw, Poland