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Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS)

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ClinicalTrials.gov Identifier: NCT04330963
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Klinik Barmelweid
Zentrum für Schlafmedizin Basel
Ospedale Regionale di Lugano
Cantonal Hospital of St. Gallen
University Hospital, Zürich
Klinik für Schlafmedizin Bar Zurzach
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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Brief Summary:
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.

Condition or disease
Narcolepsy Idiopathic Hypersomnia Hypersomnolence Disorder

Detailed Description:
An exploratory prospective, national, multi-center cohort study on clinical, electrophysiological and biological biomarkers of disease presentation and course.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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)
Healthy controls
SDB controls
Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up [ Time Frame: 36 months ]
  2. Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls [ Time Frame: 36 months ]
  2. Preptidomic profile of NT1 and NBL in comparison to controls [ Time Frame: 36 months ]
    Mass spectrometry based peptidomics of cerebrospinal fluid (CSF) for the identification of Hypocretin and approximately 6000 other neuropeptides in 10 to 20 samples for each group to be analyzed. In collaboration with the group of Prof. Matthias Mann, Max Planck Institute of Biochemistry, Planegg, Germany

  3. Gut microbiome of NT1 and NBL in comparison to controls [ Time Frame: 36 months ]
    16S based analysis of the gut microbiome based on stool samples from all participants (where available). In collaboration with the group of Prof. Andrew Macpherson, University of Bern


Biospecimen Retention:   Samples With DNA
Blood cerebrospinal fluid (CSF) Stool

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The project population consists of subjects, who were referred to the outpatient clinic / sleep center of one of the study sites for further investigation, due to complaints of EDS and / or H and / or suspected Central disorders of hypersomnolence (CDH), fulfilling inclusion / exclusion criteria and a control population as well as healthy controls.
Criteria

Inclusion Criteria:

Study participants:

  • 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:

Study participants and controls:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330963


Contacts
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Contact: Claudio L Bassetti, Prof. +41 31 63 2 30 66 ext +41316323066 Claudio.Bassetti@insel.ch
Contact: Jan Warncke, PhD +41 31 66 4 07 99 jan.warncke@insel.ch

Locations
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Switzerland
Claudio L Bassetti Recruiting
Bern, Switzerland, 3010
Contact: Claudio L Bassetti, Prof    +41316323066 ext +41316323066    Claudio.Bassetti@insel.ch   
Contact: Jan Warncke, PhD    +41 31 664 07 99    jan.warncke@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Klinik Barmelweid
Zentrum für Schlafmedizin Basel
Ospedale Regionale di Lugano
Cantonal Hospital of St. Gallen
University Hospital, Zürich
Klinik für Schlafmedizin Bar Zurzach
Investigators
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Study Director: Claudio L Bassetti, Prof. Insel Gruppe
More Information
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Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04330963    
Other Study ID Numbers: 2019-00788
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders