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International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 70
Healthy Volunteers: t
View:

∙ 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

Locations
Other Locations
Switzerland
Claudio L Bassetti
RECRUITING
Bern
Contact Information
Primary
Claudio L Bassetti, Prof.
Claudio.Bassetti@insel.ch
+41 31 63 2 30 66
Backup
Jan Warncke, PhD
jan.warncke@insel.ch
+41 31 66 4 07 99
Time Frame
Start Date: 2020-01-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 600
Treatments
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
Healthy control subjects without complaints of EDS and /or H.
SDB controls
Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.
Pediatric Hypersomnolence group
Pediatric group aged 10-18. Same criteria for inclusion and exclusion apply as for the adult group.
Sponsors
Collaborators: Leiden University Medical Center, Leiden, Netherlands, Centre Lausannios de Sommeil, University Children's Hospital Basel, Ospedale Regionale di Lugano, Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany, Zentrum für Schlafmedizin Basel, Klinik Barmelweid, Zurzach Care Klinik für Schlafmedizin, University Children's Hospital, Zurich, University of Bologna, Cantonal Hospital of St. Gallen
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov