[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387916":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":57,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":95,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Hypersomnolence group",null,"All patients referred to the outpatient clinic\u002Fsleep center for investigation due to complaints for excessive daytime sleepiness (EDS) and\u002For Hypersomnia (H) and\u002For suspected central disorder of hypersomnolence (CDH)",{"label":13,"type":10,"description":14,"interventionNames":10},"Healthy controls","Healthy control subjects without complaints of EDS and \u002For H.",{"label":16,"type":10,"description":17,"interventionNames":10},"SDB controls","Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.",{"label":19,"type":10,"description":20,"interventionNames":10},"Pediatric Hypersomnolence group","Pediatric group aged 10-18. Same criteria for inclusion and exclusion apply as for the adult group.",[22],{"name":23,"affiliation":24,"role":25},"Claudio L Bassetti, Prof.","Insel Gruppe","STUDY_DIRECTOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+41 31 63 2 30 66","+41316323066","Claudio.Bassetti@insel.ch",{"name":33,"role":28,"phone":34,"phoneExt":10,"email":35},"Jan Warncke, PhD","+41 31 66 4 07 99","jan.warncke@insel.ch",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Claudio L Bassetti","RECRUITING","Bern","3010","Switzerland","CH",{"type":45,"coordinates":46},"Point",[47,48],7.44744,46.94809,{"lat":48,"lon":47},[51,53],{"name":52,"role":28,"phone":30,"phoneExt":30,"email":31},"Claudio L Bassetti, Prof",{"name":33,"role":28,"phone":54,"phoneExt":10,"email":35},"+41 31 664 07 99",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[58,60,63,65,67,69,71,73,75,77,79],{"name":59,"class":6},"Klinik Barmelweid",{"name":61,"class":62},"Zentrum für Schlafmedizin Basel","UNKNOWN",{"name":64,"class":6},"Ospedale Regionale di Lugano",{"name":66,"class":6},"Cantonal Hospital of St. Gallen",{"name":68,"class":62},"Zurzach Care Klinik für Schlafmedizin",{"name":70,"class":6},"University Children's Hospital, Zurich",{"name":72,"class":6},"University Children's Hospital Basel",{"name":74,"class":62},"Centre Lausannios de Sommeil",{"name":76,"class":62},"Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany",{"name":78,"class":62},"Leiden University Medical Center, Leiden, Netherlands",{"name":80,"class":6},"University of Bologna","100387916","international-swiss-primary-hypersomnolence-and-narcolepsy-cohort-study-100387916",false,"NCT04330963","International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study","iSPHYNCS","Inclusion Criteria:\n\nStudy participants:\n\n* Subjective complaints of Excessive daytime sleepiness (EDS) and\u002For Hypersomnia (H) as defined above\n* EDS and\u002For H present daily or almost daily for at least 1 month prior to the consultation\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nHealthy controls:\n\n* Age and gender matched healthy subjects\n* Including blood related relatives of study participants\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nControls with Sleep disordered breathing (SDB):\n\n* Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) \\> 10 (adults) and\u002For H due to SDB: Presence of clinically significant and untreated obstructive sleep apnea (OSA) as determined by the investigator with an apnea-hypopnea-index \\>30\u002Fh\n* Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min\n* Subjective and objective improvement of EDS and\u002For H within 3 months after treatment with\n* Positive airway pressure (PAP) therapy with documented\n\n  * Reduction of apnea-hypopnea index below \\\u003C10\u002Fh\n  * Reduction of ESS by ≥ 25%\n  * MSLT mean Sleep Latency \\> 12min\n* Ability and consent to undergo electrophysiological routine assessment\n* Ability to give informed consent\n\nExclusion Criteria:\n\nStudy participants and controls:\n\n* SDB for study participants and healthy controls: Presence of clinically significant and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) as determined by the investigator or documented previously; or documentation of one of the following:\n\n  * Apnea index (AI) \\> 10 if on OSA treatment or untreated; or\n  * Clinically significant hypoventilation; or\n  * Noncompliance with primary OSA therapy\n  * except if NT1 has been diagnosed including decreased or missing cerebrospinal fluid (CSF) hypocretin\n* SDB for control population with SDB:\n\n  * Central Sleep Apnea (CSA)\n  * Noncompliance with primary OSA therapy and\u002For\n  * No reported improvement of EDS and\u002For H within 3 months of positive airway pressure (PAP) treatment\n* The following disorders\u002Fconditions that on clinical grounds are considered to be the cause of EDS \u002F H\n\n  * Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)\n  * Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury)\n  * (Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus erythematosus)\n  * Malignancy (except: Status in Remission for at least \\> 10 years)\n  * Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of major depression requiring in-hospital treatment, active substance abuse)\n  * Active infectious disease at screening\n  * Permanent medications \u002F drugs\n* Chronic infectious diseases (such as Hepatitis B\u002FC, HIV)\n* Chronic use of antibiotics\n* Recent use (\\\u003C 8 weeks) of immune-modulating drugs\n\nHealthy controls additional:\n\n* Subjective complaints of EDS and \u002F or H\n* ESS \\> 10\n* Polysomnography (PSG) with AI \\> 10\u002Fh and \u002F or PLMS Index \\> 30\u002Fh\n* MSLT mean Sleep Latency \\\u003C 12 min",true,"ALL","10 Years","70 Years",{"count":93,"type":94},600,"ESTIMATED","36 Months","OBSERVATIONAL","Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.",[99,100,101],"Narcolepsy","Idiopathic Hypersomnia","Hypersomnolence Disorder","2023-04-17",{"date":104,"type":105},"2023-04-20","ACTUAL",{"date":107,"type":105},"2020-01-06",{"date":109,"type":94},"2026-06-30",{"name":5,"class":6},1]