International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-70
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 4 trial groupsGroup A: Hypersomnolence group
Group B: Healthy controls
Group C: SDB controls
Group D: Pediatric Hypersomnolence group
Trial outcomes
Primary outcomes
1
Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
Time frame
36 months2
Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up
Time frame
36 monthsSecondary outcomes
1
Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls
Time frame
36 months2
Preptidomic profile of NT1 and NBL in comparison to controls
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
Time frame
36 months3
Gut microbiome of NT1 and NBL in comparison to controls
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
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Klinik Barmelweid
Collaborator
Zentrum für Schlafmedizin Basel
Collaborator
Ospedale Regionale di Lugano
Collaborator
Cantonal Hospital of St. Gallen
Collaborator
Zurzach Care Klinik für Schlafmedizin
Collaborator
University Children's Hospital, Zurich
Collaborator
University Children's Hospital Basel
Collaborator
Centre Lausannios de Sommeil
Collaborator
Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany
Collaborator
Leiden University Medical Center, Leiden, Netherlands
Collaborator
University of Bologna
Collaborator
Source ClinicalTrials.gov