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181 záznamů v Medvik

Článek

Data-Driven Phenotyping of Central Disorders of Hypersomnolence With Unsupervised Clustering

OBJECTIVES: Recent studies fueled doubts as to whether all currently defined central disorders of hypersomnolence ...

Gool, Jari K
Autor Gool, Jari K From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy. j.gool@amsterdamumc.nl
Zhang, Zhongxing
Autor Zhang, Zhongxing From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Oei, Martijn S S L
Autor Oei, Martijn S S L From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Mathias, Stephanie
Autor Mathias, Stephanie From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Dauvilliers, Yves
Autor Dauvilliers, Yves From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Mayer, Geert
Autor Mayer, Geert From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Plazzi, Giuseppe
Autor Plazzi, Giuseppe From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Del Rio-Villegas, Rafael
Autor Del Rio-Villegas, Rafael From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Cano, Joan Santamaria
Autor Cano, Joan Santamaria From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy
Šonka, Karel
Autor Šonka, Karel From the Sleep Wake Center SEIN Heemstede (J.K.G., R.F., G.J.L.), Stichting Epilepsie Instellingen Nederland, Heemstede Department of Neurology and Clinical Neurophysiology (J.K.G., R.F., G.J.L.), Leiden University Medical Center Department of Anatomy and Neurosciences (J.K.G., S.M.), Amsterdam UMC (Location VUmc), the Netherlands Center for Sleep Medicine, Sleep Research and Epileptology (Z.Z., R.K.), Klinik Barmelweid AG, Barmelweid, Switzerland Leiden Observatory (M.S.S.L.O.), Leiden University, the Netherlands Sleep-Wake Disorders Unit (Y.D., L.B.), Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, and Kleine-Levin Syndrome (Y.D., L.B.) Institute for Neurosciences of Montpellier INM (Y.D., L.B.), Univ Montpellier, INSERM, France Neurology Department (G.M.), Hephata Klinik, Schwalmstadt, Germany Department of Biomedical, Metabolic and Neural Sciences (G.P.), University of Modena and Reggio Emilia IRCCS Istituto delle Scienze Neurologiche di Bologna (G.P, F.P.), Bologna, Italy Neurophysiology and Sleep Disorders Unit (R.d.R.-V.), Hospital Vithas Nuestra Señora de América, Madrid Neurology Service (J.S.C.), Institut de Neurociències Hospital Clínic, University of Barcelona, Spain Neurology Department and Centre of Clinical Neurosciences (K.S.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic Helsinki Sleep Clinic (M.P.), Vitalmed Research Center, Finland Sleep Medicine Center Kempenhaeghe (S.O.), Heeze Eindhoven University of Technology (S.O.), the Netherlands Sleep and Epilepsy Unit-Clinical Neurophysiology Service (R.P.-A.), University General Hospital Gregorio Marañón, Research Institute Gregorio Marañón University Complutense of Madrid (R.P.-A.), Spain Center for Investigation and Research in Sleep (R.H.), Lausanne University Hospital, Switzerland Serviço de Neurofisiologia (A.M.d.S.), Hospital Santo António/Centro Hospitalar Universitário do Porto and UMIB-Instituto Ciências Biomédicas Abel Salazar, Universidade do Porto, Portugal Neurology Department (B.H., A.H.), Sleep Disorders Clinic, Innsbruck Medical University, Austria Department of Clinical Neurophysiology (A.W.), Institute of Psychiatry and Neurology, Warsaw, Poland Department of Sleep Medicine and Neuromuscular Disorders (A.H.), University of Münster, Germany Neurology Department (E.F.), Medical Faculty of P.J. Safarik University, University Hospital of L. Pasteur Kosice, Kosice, Slovak Republic Neurology Department (M.M.), EOC, Ospedale Regionale di Lugano, Ticino, Switzerland Department of Sleep Medicine (J.B.), National Institute of Mental Health, Klecany, Czech Republic Fundacio d`Investigacio Sanitaria de les illes balears (F.C.), Hospital Universitari Son Espases, Palma de Mallorca, Spain Department of Neurology (C.L.B., M.H.S., R.K.), Inselspital, Bern University Hospital, University of Bern, Switzerland and Department of Biomedical and Neuromotor Sciences (F.P.), University of Bologna, Italy

Neurology. 2022 ; 98 (23) : e2387-e2400. [pub] 20220418

ISSN 1526-632X
Medvik
Zdroj

BACKGROUND AND OBJECTIVES: Recent studies fueled doubts as to whether all currently defined central disorders of hypersomnolence are stable entities, especially narcolepsy type 2 and idiopathic hypersomnia. New reliable biomarkers are needed, and the question arises of whether current diagnostic criteria of hypersomnolence disorders should be reassessed. The main aim of this data-driven observational study was to see whether data-driven algorithms would segregate narcolepsy type 1 and identify more reliable subgrouping of individuals without cataplexy with new clinical biomarkers. METHODS: We used agglomerative hierarchical clustering, an unsupervised machine learning algorithm, to identify distinct hypersomnolence clusters in the large-scale European Narcolepsy Network database. We included 97 variables, covering all aspects of central hypersomnolence disorders such as symptoms, demographics, objective and subjective sleep measures, and laboratory biomarkers. We specifically focused on subgrouping of patients without cataplexy. The number of clusters was chosen to be the minimal number for which patients without cataplexy were put in distinct groups. RESULTS: We included 1,078 unmedicated adolescents and adults. Seven clusters were identified, of which 4 clusters included predominantly individuals with cataplexy. The 2 most distinct clusters consisted of 158 and 157 patients, were dominated by those without cataplexy, and among other variables, significantly differed in presence of sleep drunkenness, subjective difficulty awakening, and weekend-week sleep length difference. Patients formally diagnosed as having narcolepsy type 2 and idiopathic hypersomnia were evenly mixed in these 2 clusters. DISCUSSION: Using a data-driven approach in the largest study on central disorders of hypersomnolence to date, our study identified distinct patient subgroups within the central disorders of hypersomnolence population. Our results contest inclusion of sleep-onset REM periods in diagnostic criteria for people without cataplexy and provide promising new variables for reliable diagnostic categories that better resemble different patient phenotypes. Cluster-guided classification will result in a more solid hypersomnolence classification system that is less vulnerable to instability of single features.

MeSH
idiopatická hypersomnie * diagnóza MeSH
kataplexie * diagnóza MeSH
lidé MeSH
mladiství MeSH
narkolepsie * diagnóza farmakoterapie MeSH
poruchy nadměrné spavosti * diagnóza epidemiologie MeSH
shluková analýza MeSH
Check Tag
lidé MeSH
mladiství MeSH
Publikační typ
časopisecké články MeSH
pozorovací studie MeSH

Článek

Diagnosis of central disorders of hypersomnolence: A reappraisal by European experts

International Classification of Sleep Disorders (ICSD), particularly the chapter on central disorders of hypersomnolence ...

Sleep medicine reviews. 2020 ; 52 (-) : 101306. [pub] 20200323

Sleep Med Rev
ISSN 1532-2955
Medvik
Zdroj

The aim of this European initiative is to facilitate a structured discussion to improve the next edition of the International Classification of Sleep Disorders (ICSD), particularly the chapter on central disorders of hypersomnolence. The ultimate goal for a sleep disorders classification is to be based on the underlying neurobiological causes of the disorders with clear implication for treatment or, ideally, prevention and or healing. The current ICSD classification, published in 2014, inevitably has important shortcomings, largely reflecting the lack of knowledge about the precise neurobiological mechanisms underlying the majority of sleep disorders we currently delineate. Despite a clear rationale for the present structure, there remain important limitations that make it difficult to apply in routine clinical practice. Moreover, there are indications that the current structure may even prevent us from gaining relevant new knowledge to better understand certain sleep disorders and their neurobiological causes. We suggest the creation of a new consistent, complaint driven, hierarchical classification for central disorders of hypersomnolence; containing levels of certainty, and giving diagnostic tests, particularly the MSLT, a weighting based on its specificity and sensitivity in the diagnostic context. We propose and define three diagnostic categories (with levels of certainty): 1/"Narcolepsy" 2/"Idiopathic hypersomnia", 3/"Idiopathic excessive sleepiness" (with subtypes).

MeSH
diagnóza * MeSH
lidé MeSH
poruchy nadměrné spavosti * klasifikace diagnóza MeSH
poruchy spánku a bdění klasifikace diagnóza patofyziologie MeSH
Check Tag
lidé MeSH
Publikační typ
časopisecké články MeSH
přehledy MeSH
Geografické názvy
Evropa MeSH

Článek

Guardians of Rest? Investigating the gut microbiota in central hypersomnolence disorders

Sleep medicine. 2024 ; 113 (-) : 95-102. [pub] 20231119

Sleep Med
ISSN 1878-5506
Medvik
Zdroj

In recent years, there has been an increased interest in elucidating the influence of the gut microbiota on sleep physiology. The gut microbiota affects the central nervous system by modulating neuronal pathways through the neuroendocrine and immune system, the hypothalamus-pituitary-adrenal axis, and various metabolic pathways. The gut microbiota can also influence circadian rhythms. In this study, we observed the gut microbiota composition of patients suffering from narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. We did not observe any changes in the alpha diversity of the gut microbiota among patient groups and healthy controls. We observed changes in beta diversity in accordance with Jaccard dissimilarities between the control group and groups of patients suffering from narcolepsy type 1 and idiopathic hypersomnia. Our results indicate that both these patient groups differ from controls relative to the presence of rare bacterial taxa. However, after adjustment for various confounding factors such as BMI, age, and gender, there were no statistical differences among the groups. This indicates that the divergence in beta diversity in the narcolepsy type 1 and idiopathic hypersomnia groups did not arise due to sleep disturbances. This study implies that using metabolomics and proteomics approaches to study the role of microbiota in sleep disorders might prove beneficial.

Článek

Response to letter to the editor on guardians of rest? Investigating the gut microbiota in central hypersomnolence disorders

Sleep medicine. 2024 ; 117 (-) : 223-224. [pub] 20240304

Sleep Med
ISSN 1878-5506
Medvik
Zdroj

Článek

Nadměrná spavost v kontextu neurologických a psychiatrických onemocnění
[Excessive sleeping in the context of neurological and mental disorders]

Excessive sleepiness (hypersomnolence) is a relatively common occurrence following sleep deprivation ...

Nadměrná spavost (hypersomnolence) je relativně běžným stavem po spánkové deprivaci a také frekventovaným ...

Adamczyk, Roman
Autor Autorita Fakulta veřejných politik v Opavě

Psychiatrie pro praxi. 2019 ; 20 (3) : 114-119.

ISSN 1213-0508
Medvik
Zdroj

Nadměrná spavost (hypersomnolence) je relativně běžným stavem po spánkové deprivaci a také frekventovaným příznakem provázejícím řadu neurologických, psychiatrických a interních onemocnění, infekcí a traumat. Výskyt nadměrné spavosti u neurodegenerativních chorob, iktu, jakož i úrazů, tumorů a vybraných infekcí CNS představuje spolu s centrálními hypersomnolencemi významný klinický problém v neurologii. Zvýšený výskyt hypersomnolence je pozorován rovněž u psychiatrických diagnóz. S ohledem na dopady spavosti na kvalitu života a sociální fungování je problematika nadměrné spavosti nadále předmětem intenzivního výzkumu.

Excessive sleepiness (hypersomnolence) is a relatively common occurrence following sleep deprivation and, similarly, a prevalent symptom accompanying a number of neurological, psychiatric and other medical disorders, infections and traumas. The presence of excessive sleepiness in neurodegenerative diseases, vascular cerebral accidents, as well as CNS injuries, tumours and infections, and the existence of central disorders of hypersomnolence represent a significant clinical challenge in neurology. Increased prevalence of hypersomnolence has also been observed in mental disorders. Considering the impact of hypersomnolence on social functioning and the quality of life, excessive sleepiness is currently subject to intense clinical research.

MeSH
duševní poruchy * MeSH
klinická studie jako téma MeSH
komorbidita MeSH
lidé MeSH
nemoci nervového systému * MeSH
neurologické manifestace MeSH
poruchy nadměrné spavosti * diagnóza etiologie terapie MeSH
somatoformní poruchy MeSH
spánek MeSH
Check Tag
lidé MeSH
Publikační typ
přehledy MeSH

Článek

Idiopathic hypersomnia years after the diagnosis

with idiopathic hypersomnia years after the initial diagnosis, focusing on current subjective hypersomnolence ...

Journal of sleep research. 2024 ; 33 (2) : e14011. [pub] 20230812

J Sleep Res
ISSN 1365-2869
Medvik
Zdroj

Little attention has been paid to the long-term development of idiopathic hypersomnia symptoms and idiopathic hypersomnia comorbidities. The aim of this study was to describe the general health of patients with idiopathic hypersomnia years after the initial diagnosis, focusing on current subjective hypersomnolence and the presence of its other possible causes. Adult patients diagnosed with idiopathic hypersomnia ≥ 3 years ago at sleep centres in Prague and Kosice were invited to participate in this study. A total of 60 patients were examined (age 47.3 ± SD = 13.2 years, 66.7% women). In all participants, their hypersomnolence could not be explained by any other cause but idiopathic hypersomnia at the time of diagnosis. The mean duration of follow-up was 9.8 + 8.0 years. Fifty patients (83%) reported persisting hypersomnolence, but only 33 (55%) had no other disease that could also explain the patient's excessive daytime sleepiness and/or prolonged sleep. In two patients (3%), the diagnosis in the meantime had changed to narcolepsy type 2, and 15 patients (25%) had developed a disease or diseases potentially causing hypersomnolence since the initial diagnosis. Complete hypersomnolence resolution without stimulant treatment lasting longer than 6 months was reported by 10 patients (17%). To conclude, in a longer interval from the diagnosis of idiopathic hypersomnia, hypersomnolence may disappear or may theoretically be explained by another newly developed disease, or the diagnosis may be changed to narcolepsy type 2. Thus, after 9.8 years, only 55% of the examined patients with idiopathic hypersomnia had a typical clinical picture of idiopathic hypersomnia without doubts about the cause of the current hypersomnolence.

MeSH
dospělí MeSH
idiopatická hypersomnie * diagnóza epidemiologie farmakoterapie MeSH
komorbidita MeSH
lidé středního věku MeSH
lidé MeSH
narkolepsie * diagnóza epidemiologie MeSH
poruchy nadměrné spavosti * diagnóza epidemiologie komplikace MeSH
pozornost MeSH
Check Tag
dospělí MeSH
lidé středního věku MeSH
lidé MeSH
mužské pohlaví MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH

Článek

Central Disorders of Hypersomnolence: Association with Fatigue, Depression and Sleep Inertia Prevailing in Women

Brain sciences. 2022 ; 12 (11) : . [pub] 20221103

Brain Sci
ISSN 2076-3425
Medvik
Zdroj

Fatigue, depression, and sleep inertia are frequently underdiagnosed manifestations in narcolepsy and idiopathic hypersomnia. Our cross-sectional study design included diagnostic interview accompanied by assessment instruments and aimed to explore how these factors influence disease severity as well as to elucidate any sex predisposition. One hundred and forty-eight subjects (female 63%) were divided into narcolepsy type 1 (NT1; n = 87, female = 61%), narcolepsy type 2 (NT2; n = 22, female = 59%), and idiopathic hypersomnia (IH; n = 39, female = 69%). All subjects completed a set of questionnaires: Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scales (HADS), Fatigue Severity Scale (FSS), and Sleep Inertia Questionnaire (SIQ). In narcoleptic subjects, questionnaire data were correlated with the Narcolepsy Severity Scale (NSS), and in subjects with idiopathic hypersomnia, with the Idiopathic Hypersomnia Severity Scale (IHSS). The highest correlation in narcoleptic subjects was found between NSS and ESS (r = 0.658; p < 0.0001), as well as FSS (r = 0.506; p < 0.0001), while in subjects with idiopathic hypersomnia, the most prominent positive correlations were found between IHSS and SIQ (r = 0.894; p < 0.0001), FSS (r = 0.812; p < 0.0001), HADS depression scale (r = 0.649; p = 0.0005), and HADS anxiety scale (r = 0.528; p < 0.0001). ESS showed an analogic correlation with disease severity (r = 0.606; p < 0.0001). HADS anxiety and depression scores were higher in females (p < 0.05 and p < 0.01), with similar results for FSS and SIQ scales (p < 0.05 for both), and a trend toward higher ESS values in females (p = 0.057). Our study illustrates that more attention should be focused on pathophysiological mechanisms and associations of fatigue, depression, as well as sleep inertia in these diseases; they influence the course of both illnesses, particularly in women.

Publikační typ
časopisecké články MeSH

Článek

Narcolepsy with and without cataplexy, idiopathic hypersomnia with and without long sleep time: a cluster analysis

This is particularly the case for central disorders of hypersomnolence, with continuous changes in terminology ...

Sleep medicine. 2015 ; 16 (2) : 225-231. [pub] 20141209

Sleep Med
ISSN 1878-5506
Medvik
Zdroj

BACKGROUND: The successive editions of the International Classification of Sleep Disorders (ICSD) reflect the evolution of the concepts of various sleep disorders. This is particularly the case for central disorders of hypersomnolence, with continuous changes in terminology and divisions of narcolepsy, idiopathic hypersomnia, and recurrent hypersomnia. According to the ICSD 2nd Edition (ICSD-2), narcolepsy with cataplexy (NwithC), narcolepsy without cataplexy (Nw/oC), idiopathic hypersomnia with long sleep time (IHwithLST), and idiopathic hypersomnia without long sleep time (IHw/oLST) are four, well-defined hypersomnias of central origin. However, in the absence of biological markers, doubts have been raised as to the relevance of a division of idiopathic hypersomnia into two forms, and it is not yet clear whether Nw/oC and IHw/oLST are two distinct entities. With this in mind, it was decided to empirically review the ICSD-2 classification by using a hierarchical cluster analysis to see whether this division has some relevance, even though the terms "with long sleep time" and "without long sleep time" are inappropriate. RESULTS: The cluster analysis differentiated three main clusters: Cluster 1, "combined monosymptomatic hypersomnia/narcolepsy type 2" (people initially diagnosed with IHw/oLST and Nw/oC); Cluster 2 "polysymptomatic hypersomnia" (people initially diagnosed with IHwithLST); and Cluster 3, narcolepsy type 1 (people initially diagnosed with NwithC). CONCLUSIONS: Cluster analysis confirmed that narcolepsy type 1 and polysymptomatic hypersomnia are independent sleep disorders. People who were initially diagnosed with Nw/oC and IHw/oLST formed a single cluster, referred to as "combined monosymptomatic hypersomnia/narcolepsy type 2."

MeSH
dospělí MeSH
lidé středního věku MeSH
lidé MeSH
mladý dospělý MeSH
narkolepsie klasifikace diagnóza MeSH
polysomnografie MeSH
poruchy nadměrné spavosti klasifikace diagnóza MeSH
shluková analýza MeSH
Check Tag
dospělí MeSH
lidé středního věku MeSH
lidé MeSH
mladý dospělý MeSH
mužské pohlaví MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH
práce podpořená grantem MeSH

Článek

Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study

BACKGROUND: Idiopathic hypersomnia is a central hypersomnolence disorder mainly characterised by excessive ...

Lancet neurology. 2022 ; 21 (1) : 53-65. [pub] -

Lancet Neurol
ISSN 1474-4465
Medvik
Zdroj

BACKGROUND: Idiopathic hypersomnia is a central hypersomnolence disorder mainly characterised by excessive daytime sleepiness, with prolonged night-time sleep and pronounced sleep inertia. Until August, 2021, no medication had regulatory approval for the treatment of idiopathic hypersomnia. This study aimed to evaluate the safety and efficacy of lower-sodium oxybate in idiopathic hypersomnia. METHODS: This was a phase 3, multicentre (50 specialist sleep centres; six EU countries and the USA), placebo-controlled, double-blind, randomised withdrawal study. Participants (aged 18-75 years) with idiopathic hypersomnia (meeting criteria from the International Classification of Sleep Disorders, 2nd or 3rd editions) began lower-sodium oxybate treatment (oral solution once or twice nightly) in an open-label titration and optimisation period (10-14 weeks), followed by a 2-week, open-label, stable-dose period. After these open-label periods, participants were randomised (1:1) by means of an interactive web recognition system, stratified by participants' baseline medication use, to either placebo or lower-sodium oxybate (individually optimised dose; range 2·5-9·0 g/night) during a 2-week, double-blind, randomised withdrawal period. To maintain masking of treatment assignment, placebo and lower-sodium oxybate oral solutions were matched in volume, appearance, and taste. During the double-blind, randomised withdrawal period, participants and investigators were unaware of treatment assignments. The primary efficacy endpoint was change in Epworth Sleepiness Scale (ESS) score from the end of the stable-dose period to the end of the double-blind, randomised withdrawal period, which was assessed in the modified intention-to-treat population (defined as all participants who were randomly assigned, took at least one dose of study medication during the double blind, randomised withdrawal period, and had at least one set of post-randomisation assessments for the primary or key secondary endpoints). Adverse events were assessed in the safety population (defined as all participants who took at least one dose of study medication). This study is registered at ClinicalTrials.gov, NCT03533114, and at EU Clinical Trials, 2018-001311-79, and is complete. FINDINGS: Between Nov 27, 2018, and March 6, 2020, 154 participants were enrolled and comprised the safety population. ESS scores decreased from a mean of 15·7 (SD 3·8) at baseline to 6·1 (4·0) by the end of the stable-dose period. After the open-label periods, 115 participants were randomly assigned either placebo (n=59) or lower-sodium oxybate (n=56) and comprised the modified intention-to-treat population. During the double-blind, randomised withdrawal period, ESS scores increased (worsened) in participants randomly assigned to placebo but remained stable in those assigned to lower-sodium oxybate (least squares mean difference -6·5; 95% CI -8·0 to -5·0; p<0·0001). Treatment-emergent adverse events included nausea (34 [22%] of 154), headache (27 [18%] of 154), dizziness (19 [12%] of 154), anxiety (17 [11%] 154), and vomiting (17 [11%] 154). No deaths were reported during the study. INTERPRETATION: Lower-sodium oxybate treatment resulted in a clinically meaningful improvement in idiopathic hypersomnia symptoms, with an overall safety profile consistent with that reported for narcolepsy. Lower-sodium oxybate was approved in August, 2021, by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults. FUNDING: Jazz Pharmaceuticals.