NarcolepsyiSPHYNCSNCT04330963
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
An observational study of Narcolepsy and Idiopathic Hypersomnia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2020to 30 Jun 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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:
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Claudio L Bassetti
Bern, 3010
Claudio L Bassetti, Prof, +41316323066 ext. +41316323066, Claudio.Bassetti@insel.ch
Jan Warncke, PhD, +41 31 664 07 99, jan.warncke@insel.ch
About this study
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.
Read the detailed description
An exploratory prospective, national, multi-center cohort study on clinical, electrophysiological and biological biomarkers of disease presentation and course.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- Medical subject headings
- Narcolepsy, Idiopathic Hypersomnia, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
Measured: 36 months
Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up
Measured: 36 months
Secondary outcomes (3)
Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls
Measured: 36 months
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
Measured: 36 months
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start6 Jan 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Barmelweid, Zentrum für Schlafmedizin Basel, Ospedale Regionale di Lugano, Cantonal Hospital of St. Gallen, Zurzach Care Klinik für Schlafmedizin, University Children's Hospital, Zurich, University Children's Hospital Basel, Centre Lausannios de Sommeil, Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany, Leiden University Medical Center, Leiden, Netherlands, University of Bologna
- Responsible party
- Sponsor
- Investigators
- Claudio L Bassetti, Prof., Study director, Insel Gruppe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330963
- Sponsor's protocol ID
- 2019-00788
- Other IDs
- 2019
- Acronym
- iSPHYNCS
- Status last verified
- Apr 2023
- First submitted
- 6 Jan 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31324898Latorre 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.
PubMed 30232458Bassetti 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.
PubMed 9278632Dietmann 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.
PubMed 33813771Morand R, Fregolente L, van der Meer J, Wenz ES, Helmy A, Brigato L, Warncke JD, Zub K, Khatami R, Zhang Z, von Manitius S, Miano S, Acker J, Strub M, Kallweit U, Lammers GJ, Tzovara A, Bassetti CLA, Mougiakakou S, Schmidt MH. iSPHYNCS: Unsupervised Clustering in Questionnaires and Metadata Reveals Distinct Subtypes in the Narcolepsy Borderland. J Sleep Res. 2026 Aug;35(4):e70294. doi: 10.1111/jsr.70294. Epub 2026 Feb 9.
PubMed 41657285
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
- ClinicalTrials.gov ID
- NCT04330963
- Acronym / sponsor ID
- iSPHYNCS / 2019-00788
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Klinik Barmelweid, Zentrum für Schlafmedizin Basel, Ospedale Regionale di Lugano, Cantonal Hospital of St. Gallen, Zurzach Care Klinik für Schlafmedizin, University Children's Hospital, Zurich, University Children's Hospital Basel, Centre Lausannios de Sommeil, Private Universität Witten-Herdecke and Orfea Fachklinik für Schlafmedizin, Witten, Germany, Leiden University Medical Center, Leiden, Netherlands, University of Bologna
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An exploratory prospective, national, multi-center cohort study on clinical, electrophysiological and biological biomarkers of disease presentation and course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (20 listed)
- 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
- Age and gender matched healthy subjects
Key exclusion criteria (26 listed)
- 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:
- SDB for control population with SDB:
- The following disorders/conditions that on clinical grounds are considered to be the cause of EDS / H
- Chronic infectious diseases (such as Hepatitis B/C, HIV)
- Chronic use of antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
Time frame: 36 months
Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up
Time frame: 36 months
3 secondary outcomes
Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls
Time frame: 36 months
Preptidomic profile of NT1 and NBL in comparison to controls
Time frame: 36 months
Gut microbiome of NT1 and NBL in comparison to controls
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 31324898Bassetti 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.
- Background: PubMed 30232458Latorre 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.
- Background: PubMed 9278632Bassetti 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.
- Background: PubMed 33813771Dietmann 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.
- Derived from this study: PubMed 41657285Morand R, Fregolente L, van der Meer J, Wenz ES, Helmy A, Brigato L, Warncke JD, Zub K, Khatami R, Zhang Z, von Manitius S, Miano S, Acker J, Strub M, Kallweit U, Lammers GJ, Tzovara A, Bassetti CLA, Mougiakakou S, Schmidt MH. iSPHYNCS: Unsupervised Clustering in Questionnaires and Metadata Reveals Distinct Subtypes in the Narcolepsy Borderland. J Sleep Res. 2026 Aug;35(4):e70294. doi: 10.1111/jsr.70294. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio L Bassetti, Prof. study director
Insel Gruppe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy and Idiopathic Hypersomnia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio L Bassetti, Prof. (+41 31 63 2 30 66 ext. +41316323066, Claudio.Bassetti@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330963, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.