International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
NCT ID: NCT04330963
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2020-01-06
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hypersomnolence group
All patients referred to the outpatient clinic/sleep center for investigation due to complaints for excessive daytime sleepiness (EDS) and/or Hypersomnia (H) and/or suspected central disorder of hypersomnolence (CDH)
No interventions assigned to this group
Healthy controls
Healthy control subjects without complaints of EDS and /or H.
No interventions assigned to this group
SDB controls
Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.
No interventions assigned to this group
Pediatric Hypersomnolence group
Pediatric group aged 10-18. Same criteria for inclusion and exclusion apply as for the adult group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subjective complaints of Excessive daytime sleepiness (EDS) and/or Hypersomnia (H) as defined above
* EDS and/or H present daily or almost daily for at least 1 month prior to the consultation
* Ability and consent to undergo electrophysiological routine assessment
* Ability to give informed consent
Healthy controls:
* Age and gender matched healthy subjects
* Including blood related relatives of study participants
* Ability and consent to undergo electrophysiological routine assessment
* Ability to give informed consent
Controls with Sleep disordered breathing (SDB):
* Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) \> 10 (adults) and/or 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/h
* Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min
* Subjective and objective improvement of EDS and/or H within 3 months after treatment with
* Positive airway pressure (PAP) therapy with documented
* Reduction of apnea-hypopnea index below \<10/h
* Reduction of ESS by ≥ 25%
* MSLT mean Sleep Latency \> 12min
* Ability and consent to undergo electrophysiological routine assessment
* Ability to give informed consent
Exclusion Criteria
* 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:
* Apnea index (AI) \> 10 if on OSA treatment or untreated; or
* Clinically significant hypoventilation; or
* Noncompliance with primary OSA therapy
* except if NT1 has been diagnosed including decreased or missing cerebrospinal fluid (CSF) hypocretin
* SDB for control population with SDB:
* Central Sleep Apnea (CSA)
* Noncompliance with primary OSA therapy and/or
* No reported improvement of EDS and/or H within 3 months of positive airway pressure (PAP) treatment
* The following disorders/conditions that on clinical grounds are considered to be the cause of EDS / H
* Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)
* Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury)
* (Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus erythematosus)
* Malignancy (except: Status in Remission for at least \> 10 years)
* Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of major depression requiring in-hospital treatment, active substance abuse)
* Active infectious disease at screening
* Permanent medications / drugs
* Chronic infectious diseases (such as Hepatitis B/C, HIV)
* Chronic use of antibiotics
* Recent use (\< 8 weeks) of immune-modulating drugs
Healthy controls additional:
* Subjective complaints of EDS and / or H
* ESS \> 10
* Polysomnography (PSG) with AI \> 10/h and / or PLMS Index \> 30/h
* MSLT mean Sleep Latency \< 12 min
10 Years
70 Years
ALL
Yes
Sponsors
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Klinik Barmelweid
OTHER
Zentrum für Schlafmedizin Basel
UNKNOWN
Ospedale Regionale di Lugano
OTHER
Cantonal Hospital of St. Gallen
OTHER
Zurzach Care Klinik für Schlafmedizin
UNKNOWN
University Children's Hospital, Zurich
OTHER
University Children's Hospital Basel
OTHER
Centre Lausannios de Sommeil
UNKNOWN
Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany
UNKNOWN
Leiden University Medical Center, Leiden, Netherlands
UNKNOWN
University of Bologna, Bologna, Italy
UNKNOWN
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Claudio L Bassetti, Prof.
Role: STUDY_DIRECTOR
Insel Gruppe
Locations
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Claudio L Bassetti
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
Latorre D, Kallweit U, Armentani E, Foglierini M, Mele F, Cassotta A, Jovic S, Jarrossay D, Mathis J, Zellini F, Becher B, Lanzavecchia A, Khatami R, Manconi M, Tafti M, Bassetti CL, Sallusto F. T cells in patients with narcolepsy target self-antigens of hypocretin neurons. Nature. 2018 Oct;562(7725):63-68. doi: 10.1038/s41586-018-0540-1. Epub 2018 Sep 19.
Bassetti C, Aldrich MS. Idiopathic hypersomnia. A series of 42 patients. Brain. 1997 Aug;120 ( Pt 8):1423-35. doi: 10.1093/brain/120.8.1423.
Dietmann A, Wenz E, van der Meer J, Ringli M, Warncke JD, Edwards E, Schmidt MH, Bernasconi CA, Nirkko A, Strub M, Miano S, Manconi M, Acker J, von Manitius S, Baumann CR, Valko PO, Yilmaz B, Brunner AD, Tzovara A, Zhang Z, Largiader CR, Tafti M, Latorre D, Sallusto F, Khatami R, Bassetti CLA. The Swiss Primary Hypersomnolence and Narcolepsy Cohort study (SPHYNCS): Study protocol for a prospective, multicentre cohort observational study. J Sleep Res. 2021 Oct;30(5):e13296. doi: 10.1111/jsr.13296. Epub 2021 Apr 4.
Other Identifiers
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2019-00788
Identifier Type: -
Identifier Source: org_study_id
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