Comparing Treatment Effect Measurements in Narcolepsy: The Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test
Identifieur interne : 003014 ( Main/Exploration ); précédent : 003013; suivant : 003015Comparing Treatment Effect Measurements in Narcolepsy: The Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test
Auteurs : Astrid Van Der Heide [Pays-Bas] ; Mojca K. M. Van Schie [Pays-Bas] ; Gert Jan Lammers [Pays-Bas] ; Yves Dauvilliers [France] ; Isabelle Arnulf [France] ; Geert Mayer [Allemagne] ; Claudio L. Bassetti [Suisse] ; Claire-Li Ding [France] ; Philippe Lehert [Belgique, Australie] ; J. Gert Van Dijk [Pays-Bas]Source :
- Sleep [ 0161-8105 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Attention (), Cataplexie (physiopathologie), Cataplexie (psychologie), Cataplexie (traitement médicamenteux), Composés benzhydryliques (usage thérapeutique), Facteurs temps, Femelle, Humains, Mâle, Méthode en double aveugle, Narcolepsie (physiopathologie), Narcolepsie (psychologie), Narcolepsie (traitement médicamenteux), Phases du sommeil (), Pipéridines (usage thérapeutique), Reproductibilité des résultats, Résultat thérapeutique, Vigilance ().
- MESH :
- physiopathologie : Cataplexie, Narcolepsie.
- psychologie : Cataplexie, Narcolepsie.
- traitement médicamenteux : Cataplexie, Narcolepsie.
- usage thérapeutique : Composés benzhydryliques, Pipéridines.
- Adulte, Attention, Facteurs temps, Femelle, Humains, Mâle, Méthode en double aveugle, Phases du sommeil, Reproductibilité des résultats, Résultat thérapeutique, Vigilance.
English descriptors
- KwdEn :
- Adult, Attention (drug effects), Benzhydryl Compounds (therapeutic use), Cataplexy (drug therapy), Cataplexy (physiopathology), Cataplexy (psychology), Double-Blind Method, Female, Humans, Male, Narcolepsy (drug therapy), Narcolepsy (physiopathology), Narcolepsy (psychology), Piperidines (therapeutic use), Reproducibility of Results, Sleep Stages (drug effects), Time Factors, Treatment Outcome, Wakefulness (drug effects).
- MESH :
- chemical , therapeutic use : Benzhydryl Compounds, Piperidines.
- drug effects : Attention, Sleep Stages, Wakefulness.
- drug therapy : Cataplexy, Narcolepsy.
- physiopathology : Cataplexy, Narcolepsy.
- psychology : Cataplexy, Narcolepsy.
- Adult, Double-Blind Method, Female, Humans, Male, Reproducibility of Results, Time Factors, Treatment Outcome.
Abstract
To validate the Sustained Attention to Response Task (SART) as a treatment effect measure in narcolepsy, and to compare the SART with the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).
Validation of treatment effect measurements within a randomized controlled trial (RCT).
Ninety-five patients with narcolepsy with or without cataplexy.
The RCT comprised a double-blind, parallel-group, multicenter trial comparing the effects of 8-w treatments with pitolisant (BF2.649), modafinil, or placebo (NCT01067222). MWT, ESS, and SART were administered at baseline and after an 8-w treatment period. The severity of excessive daytime sleepiness and cataplexy was also assessed using the Clinical Global Impression scale (CGI-C).
The SART, MWT, and ESS all had good reliability, obtained for the SART and MWT using two to three sessions in 1 day. The ability to distinguish responders from nonresponders, classified using the CGI-C score, was high for all measures, with a high performance for the SART (r = 0.61) and the ESS (r = 0.54).
The Sustained Attention to Response Task is a valid and easy-to-administer measure to assess treatment effects in narcolepsy, enhanced by combining it with the Epworth Sleepiness Scale.
van der Heide A, van Schie MK, Lammers GJ, Dauvilliers Y, Arnulf I, Mayer G, Bassetti CL, Ding CL, Lehert P, van Dijk JG. Comparing treatment effect measurements in narcolepsy: the Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test.
Url:
DOI: 10.5665/sleep.4810
PubMed: 25902810
PubMed Central: 4481014
Affiliations:
- Allemagne, Australie, Belgique, France, Pays-Bas, Suisse
- Canton de Berne, District de Giessen, Hesse (Land), Hollande-Méridionale, Languedoc-Roussillon, Occitanie (région administrative), Victoria (État), Île-de-France
- Berne, Leyde, Marbourg, Melbourne, Montpellier, Paris
- Université de Berne, Université de Melbourne
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Le document en format XML
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M." last="Van Schie">Mojca K. M. Van Schie</name><affiliation wicri:level="3"><nlm:aff id="aff1">Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Lammers, Gert Jan" sort="Lammers, Gert Jan" uniqKey="Lammers G" first="Gert Jan" last="Lammers">Gert Jan Lammers</name><affiliation wicri:level="3"><nlm:aff id="aff1">Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">SleepWake Center SEIN, Heemstede, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>SleepWake Center SEIN, Heemstede</wicri:regionArea><wicri:noRegion>Heemstede</wicri:noRegion></affiliation></author><author><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name><affiliation wicri:level="3"><nlm:aff id="aff3">Sleep Unit, Reference Center for Narcolepsy, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Sleep Unit, Reference Center for Narcolepsy, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name><affiliation wicri:level="3"><nlm:aff id="aff4">Sleep Disorder Unit, Pitié-Salpêtrière Hospital, Reference Center for Narcolepsy, and Pierre and Marie Curie University, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Sleep Disorder Unit, Pitié-Salpêtrière Hospital, Reference Center for Narcolepsy, and Pierre and Marie Curie University, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mayer, Geert" sort="Mayer, Geert" uniqKey="Mayer G" first="Geert" last="Mayer">Geert Mayer</name><affiliation wicri:level="1"><nlm:aff id="aff5">Sleep Unit, Hephata Clinic, Schwalmstadt-Treysa, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Sleep Unit, Hephata Clinic, Schwalmstadt-Treysa</wicri:regionArea><wicri:noRegion>Schwalmstadt-Treysa</wicri:noRegion><wicri:noRegion>Schwalmstadt-Treysa</wicri:noRegion><wicri:noRegion>Schwalmstadt-Treysa</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:aff id="aff6">Philipps University Marburg, Department of Neurology, Marburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Philipps University Marburg, Department of Neurology, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Bassetti, Claudio L" sort="Bassetti, Claudio L" uniqKey="Bassetti C" first="Claudio L." last="Bassetti">Claudio L. Bassetti</name><affiliation wicri:level="4"><nlm:aff id="aff7">Sleep Unit, Department of Neurology, University of Bern, Bern, Switzerland</nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Sleep Unit, Department of Neurology, University of Bern, Bern</wicri:regionArea><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region><settlement type="city">Berne</settlement></placeName><orgName type="university">Université de Berne</orgName></affiliation></author><author><name sortKey="Ding, Claire Li" sort="Ding, Claire Li" uniqKey="Ding C" first="Claire-Li" last="Ding">Claire-Li Ding</name><affiliation wicri:level="3"><nlm:aff id="aff8">Bioprojet,Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bioprojet,Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name><affiliation wicri:level="1"><nlm:aff id="aff9">University of Louvain, Faculty of Economics, Department of Statistics, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>University of Louvain, Faculty of Economics, Department of Statistics</wicri:regionArea><wicri:noRegion>Department of Statistics</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:aff id="aff10">University of Melbourne, Faculty of Medicine, Department of Statistics, Melbourne, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>University of Melbourne, Faculty of Medicine, Department of Statistics, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Van Dijk, J Gert" sort="Van Dijk, J Gert" uniqKey="Van Dijk J" first="J. Gert" last="Van Dijk">J. Gert Van Dijk</name><affiliation wicri:level="3"><nlm:aff id="aff1">Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology and Clinical Neurophysiology, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author></analytic><series><title level="j">Sleep</title><idno type="ISSN">0161-8105</idno><idno type="eISSN">1550-9109</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Attention (drug effects)</term><term>Benzhydryl Compounds (therapeutic use)</term><term>Cataplexy (drug therapy)</term><term>Cataplexy (physiopathology)</term><term>Cataplexy (psychology)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Narcolepsy (drug therapy)</term><term>Narcolepsy (physiopathology)</term><term>Narcolepsy (psychology)</term><term>Piperidines (therapeutic use)</term><term>Reproducibility of Results</term><term>Sleep Stages (drug effects)</term><term>Time Factors</term><term>Treatment Outcome</term><term>Wakefulness (drug effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Attention ()</term><term>Cataplexie (physiopathologie)</term><term>Cataplexie (psychologie)</term><term>Cataplexie (traitement médicamenteux)</term><term>Composés benzhydryliques (usage thérapeutique)</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Narcolepsie (physiopathologie)</term><term>Narcolepsie (psychologie)</term><term>Narcolepsie (traitement médicamenteux)</term><term>Phases du sommeil ()</term><term>Pipéridines (usage thérapeutique)</term><term>Reproductibilité des résultats</term><term>Résultat thérapeutique</term><term>Vigilance ()</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzhydryl Compounds</term><term>Piperidines</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Attention</term><term>Sleep Stages</term><term>Wakefulness</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Cataplexy</term><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Cataplexie</term><term>Narcolepsie</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Cataplexy</term><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Cataplexie</term><term>Narcolepsie</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Cataplexy</term><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Cataplexie</term><term>Narcolepsie</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Composés benzhydryliques</term><term>Pipéridines</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Reproducibility of Results</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Attention</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Phases du sommeil</term><term>Reproductibilité des résultats</term><term>Résultat thérapeutique</term><term>Vigilance</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Study Objectives:</title><p>To validate the Sustained Attention to Response Task (SART) as a treatment effect measure in narcolepsy, and to compare the SART with the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).</p></sec><sec><title>Design:</title><p>Validation of treatment effect measurements within a randomized controlled trial (RCT).</p></sec><sec><title>Patients:</title><p>Ninety-five patients with narcolepsy with or without cataplexy.</p></sec><sec><title>Interventions:</title><p>The RCT comprised a double-blind, parallel-group, multicenter trial comparing the effects of 8-w treatments with pitolisant (BF2.649), modafinil, or placebo (NCT01067222). MWT, ESS, and SART were administered at baseline and after an 8-w treatment period. The severity of excessive daytime sleepiness and cataplexy was also assessed using the Clinical Global Impression scale (CGI-C).</p></sec><sec><title>Measurements and Results:</title><p>The SART, MWT, and ESS all had good reliability, obtained for the SART and MWT using two to three sessions in 1 day. The ability to distinguish responders from nonresponders, classified using the CGI-C score, was high for all measures, with a high performance for the SART (r = 0.61) and the ESS (r = 0.54).</p></sec><sec><title>Conclusions:</title><p>The Sustained Attention to Response Task is a valid and easy-to-administer measure to assess treatment effects in narcolepsy, enhanced by combining it with the Epworth Sleepiness Scale.</p></sec><sec><title>Citation:</title><p>van der Heide A, van Schie MK, Lammers GJ, Dauvilliers Y, Arnulf I, Mayer G, Bassetti CL, Ding CL, Lehert P, van Dijk JG. Comparing treatment effect measurements in narcolepsy: the Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test. <italic>SLEEP</italic> 2015;38(7):1051–1058.</p></sec></div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>France</li><li>Pays-Bas</li><li>Suisse</li></country><region><li>Canton de Berne</li><li>District de Giessen</li><li>Hesse (Land)</li><li>Hollande-Méridionale</li><li>Languedoc-Roussillon</li><li>Occitanie (région administrative)</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Berne</li><li>Leyde</li><li>Marbourg</li><li>Melbourne</li><li>Montpellier</li><li>Paris</li></settlement><orgName><li>Université de Berne</li><li>Université de Melbourne</li></orgName></list><tree><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Van Der Heide, Astrid" sort="Van Der Heide, Astrid" uniqKey="Van Der Heide A" first="Astrid" last="Van Der Heide">Astrid Van Der Heide</name></region><name sortKey="Lammers, Gert Jan" sort="Lammers, Gert Jan" uniqKey="Lammers G" first="Gert Jan" last="Lammers">Gert Jan Lammers</name><name sortKey="Lammers, Gert Jan" sort="Lammers, Gert Jan" uniqKey="Lammers G" first="Gert Jan" last="Lammers">Gert Jan Lammers</name><name sortKey="Van Dijk, J Gert" sort="Van Dijk, J Gert" uniqKey="Van Dijk J" first="J. Gert" last="Van Dijk">J. Gert Van Dijk</name><name sortKey="Van Schie, Mojca K M" sort="Van Schie, Mojca K M" uniqKey="Van Schie M" first="Mojca K. M." last="Van Schie">Mojca K. M. Van Schie</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name></region><name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name><name sortKey="Ding, Claire Li" sort="Ding, Claire Li" uniqKey="Ding C" first="Claire-Li" last="Ding">Claire-Li Ding</name></country><country name="Allemagne"><noRegion><name sortKey="Mayer, Geert" sort="Mayer, Geert" uniqKey="Mayer G" first="Geert" last="Mayer">Geert Mayer</name></noRegion><name sortKey="Mayer, Geert" sort="Mayer, Geert" uniqKey="Mayer G" first="Geert" last="Mayer">Geert Mayer</name></country><country name="Suisse"><region name="Canton de Berne"><name sortKey="Bassetti, Claudio L" sort="Bassetti, Claudio L" uniqKey="Bassetti C" first="Claudio L." last="Bassetti">Claudio L. Bassetti</name></region></country><country name="Belgique"><noRegion><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name></noRegion></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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