Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment.
Claudio L A Bassetti, Antoine Adamantidis, Denis Burdakov...
https://pubmed.ncbi.nlm.nih.gov/31324898Actively Recruiting
Age: 10Years - 70Years
All Genders
Healthy Volunteers
ID04330963
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-04-20
600
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
K
Klinik Barmelweid
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting the International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study to explore how diseases like narcolepsy and idiopathic hypersomnia present and progress over time. This study aims to identify clinical, electrophysiological, and biological markers that may help understand these conditions better. It is a prospective, national, multi-center observational cohort study involving both adults and pediatric participants. Participants include patients referred for investigation of excessive daytime sleepiness (EDS), hypersomnia, or suspected central disorders of hypersomnolence, as well as healthy controls and patients with sleep-disordered breathing (SDB) who improve with therapy. The study includes a pediatric group aged 10 to 18 years with similar criteria. Participants undergo routine electrophysiological assessments and provide biological samples to explore biomarkers. Healthy controls and SDB controls are also included for comparison. During the study, participants will be followed for up to 36 months with assessments including clinical evaluations, electrophysiological tests, and biological sample collection to analyze immune markers and microbiome profiles. Researchers will monitor diagnoses over time, focusing on narcolepsy type 1 and other central hypersomnolence disorders. The study measures include the proportion of participants diagnosed with different conditions and the presence of specific immune cells and microbiome differences. Participation involves regular follow-up visits and informed consent procedures.
CONDITIONS
Brief Title
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Who Can Participate
Age: 10Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Subjective complaints of excessive daytime sleepiness (EDS) and/or hypersomnia (H) present daily or almost daily for at least 1 month
- Ability and consent to undergo routine electrophysiological assessments
- Ability to give informed consent
- Healthy controls must be age and gender matched, including blood relatives of study participants
- Controls with sleep-disordered breathing must have EDS with Epworth Sleepiness Scale (ESS) > 10 and clinically significant obstructive sleep apnea (OSA) with apnea-hypopnea index >30/h
- Controls with sleep-disordered breathing must show improvement in EDS and/or H within 3 months of positive airway pressure therapy
- Pediatric participants aged 10 to 18 years with the same criteria as adults
You will not qualify if you...
- Presence of clinically significant and untreated obstructive or central sleep apnea for study participants and healthy controls
- Apnea index >10 if on OSA treatment or untreated
- Clinically significant hypoventilation
- Noncompliance with primary OSA therapy, except if narcolepsy type 1 has been diagnosed with CSF hypocretin deficiency
- Central sleep apnea and no improvement after treatment in control population with sleep-disordered breathing
- Other sleep disorders such as restless legs syndrome with periodic leg movement, sleepwalking, circadian disorders
- Neurological disorders including stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury
- Autoimmune and systemic disorders like Hashimoto thyroiditis, Crohn's disease, ulcerative colitis, type I diabetes, systemic lupus erythematosus
- Malignancy except in remission for at least 10 years
- Unstable psychiatric disorders including acute psychosis, suicidal episodes, major depression requiring hospitalization, active substance abuse
- Active infectious disease at screening
- Use of permanent medications or drugs
- Chronic infectious diseases such as Hepatitis B, C, or HIV
- Chronic use of antibiotics
- Recent use (within 8 weeks) of immune-modulating drugs
- Healthy controls with subjective complaints of EDS or H, ESS > 10, abnormal polysomnography with apnea index >10/h or periodic limb movement index >30/h, or mean sleep latency <12 minutes on multiple sleep latency test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Initial assessments at enrollment
Participants undergo clinical, electrophysiological, and biological assessments to investigate excessive daytime sleepiness and hypersomnia symptoms.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to 36 months
Participants are followed over time to observe disease presentation and course, including diagnosis and biomarker changes.
Periodic follow-up visits during 36 months
Trial Site Locations
Total: 1 location
1
Claudio L Bassetti
Bern, Switzerland, 3010
Actively Recruiting
Loading map...
Research Team
C
Claudio L Bassetti, Prof.
J
Jan Warncke, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
T cells in patients with narcolepsy target self-antigens of hypocretin neurons.
Daniela Latorre, Ulf Kallweit, Eric Armentani...
https://pubmed.ncbi.nlm.nih.gov/30232458Idiopathic hypersomnia. A series of 42 patients.
C Bassetti, M S Aldrich
https://pubmed.ncbi.nlm.nih.gov/9278632The Swiss Primary Hypersomnolence and Narcolepsy Cohort study (SPHYNCS): Study protocol for a prospective, multicentre cohort observational study.
Anelia Dietmann, Elena Wenz, Julia van der Meer...
https://pubmed.ncbi.nlm.nih.gov/33813771iSPHYNCS: Unsupervised Clustering in Questionnaires and Metadata Reveals Distinct Subtypes in the Narcolepsy Borderland.
Rafael Morand, Livia Fregolente, Julia van der Meer...
https://pubmed.ncbi.nlm.nih.gov/41657285