- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330963
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (iSPHYNCS)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Claudio L Bassetti, Prof.
- Phone Number: +41316323066 +41 31 63 2 30 66
- Email: Claudio.Bassetti@insel.ch
Study Contact Backup
- Name: Jan Warncke, PhD
- Phone Number: +41 31 66 4 07 99
- Email: jan.warncke@insel.ch
Study Locations
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Bern, Switzerland, 3010
- Recruiting
- Claudio L Bassetti
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Contact:
- Claudio L Bassetti, Prof
- Phone Number: +41316323066 +41316323066
- Email: Claudio.Bassetti@insel.ch
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Contact:
- Jan Warncke, PhD
- Phone Number: +41 31 664 07 99
- Email: jan.warncke@insel.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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)
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Healthy controls
Healthy control subjects without complaints of EDS and /or H.
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SDB controls
Patients with EDS and diagnosis of severe sleep related breathing disorder (SBD) significantly improving with therapy.
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Pediatric Hypersomnolence group
Pediatric group aged 10-18.
Same criteria for inclusion and exclusion apply as for the adult group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
Time Frame: 36 months
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36 months
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Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up
Time Frame: 36 months
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls
Time Frame: 36 months
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36 months
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Preptidomic profile of NT1 and NBL in comparison to controls
Time Frame: 36 months
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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
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36 months
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Gut microbiome of NT1 and NBL in comparison to controls
Time Frame: 36 months
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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
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36 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Claudio L Bassetti, Prof., Insel Gruppe
Publications and helpful links
General Publications
- Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.
- Latorre D, Kallweit U, Armentani E, Foglierini M, Mele F, Cassotta A, Jovic S, Jarrossay D, Mathis J, Zellini F, Becher B, Lanzavecchia A, Khatami R, Manconi M, Tafti M, Bassetti CL, Sallusto F. T cells in patients with narcolepsy target self-antigens of hypocretin neurons. Nature. 2018 Oct;562(7725):63-68. doi: 10.1038/s41586-018-0540-1. Epub 2018 Sep 19.
- Bassetti C, Aldrich MS. Idiopathic hypersomnia. A series of 42 patients. Brain. 1997 Aug;120 ( Pt 8):1423-35. doi: 10.1093/brain/120.8.1423.
- Dietmann A, Wenz E, van der Meer J, Ringli M, Warncke JD, Edwards E, Schmidt MH, Bernasconi CA, Nirkko A, Strub M, Miano S, Manconi M, Acker J, von Manitius S, Baumann CR, Valko PO, Yilmaz B, Brunner AD, Tzovara A, Zhang Z, Largiader CR, Tafti M, Latorre D, Sallusto F, Khatami R, Bassetti CLA. The Swiss Primary Hypersomnolence and Narcolepsy Cohort study (SPHYNCS): Study protocol for a prospective, multicentre cohort observational study. J Sleep Res. 2021 Oct;30(5):e13296. doi: 10.1111/jsr.13296. Epub 2021 Apr 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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