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, University of Bologna, Bologna, Italy, 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, Cantonal Hospital of St. Gallen
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov