International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT04330963
Status
Recruiting
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Conditions

  • Hypersomnolence Disorder
  • Idiopathic Hypersomnia
  • Narcolepsy

Eligibility Criteria

Sex
ALL
Age
10 Years - 70 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jan 6, 2020
Status verified
Apr 2023
Primary completion
Dec 30, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: 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)
  • Arm: Healthy controls
    Healthy control subjects without complaints of EDS and /or H.
  • Arm: SDB controls
    Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.
  • Arm: Pediatric Hypersomnolence group
    Pediatric group aged 10-18. Same criteria for inclusion and exclusion apply as for the adult group.

Primary Outcome Measure

Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up [ Time Frame: 36 months ]

Central Contacts

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