Actively Recruiting
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
338 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
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.
CONDITIONS
Official Title
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjective complaints of excessive daytime sleepiness (EDS) and/or hypersomnia present daily or almost daily for at least 1 month prior to consultation
- Ability and consent to undergo electrophysiological routine assessment
- Ability to give informed consent
- Age between 10 and 70 years
- For healthy controls: age and gender matched, including blood-related relatives, ability and consent to undergo electrophysiological routine assessment, and ability to give informed consent
- For controls with sleep disordered breathing (SDB): subjective complaints of EDS with Epworth Sleepiness Scale (ESS) > 10 (adults) and/or hypersomnia due to SDB with clinically significant and untreated obstructive sleep apnea (OSA) with apnea-hypopnea-index >30/h
- Multiple sleep-latency test mean sleep latency ≤ 8 min
- Subjective and objective improvement of EDS and/or hypersomnia within 3 months after positive airway pressure therapy with documented reduction of apnea-hypopnea index below <10/h, reduction of ESS by ≥ 25%, and mean sleep latency > 12 min
You will not qualify if you...
- Presence of clinically significant and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) for study participants and healthy controls
- Apnea index (AI) > 10 if on OSA treatment or untreated
- Clinically significant hypoventilation
- Noncompliance with primary OSA therapy, except if Narcolepsy type 1 diagnosed with decreased or missing cerebrospinal fluid hypocretin
- For control population with SDB: central sleep apnea, noncompliance with primary OSA therapy, or no improvement of EDS/hypersomnia within 3 months of positive airway pressure treatment
- Other sleep disorders causing EDS/hypersomnia such as restless legs syndrome with periodic leg movement syndrome, sleepwalking, clear-cut circadian disorder
- Other neurological disorders such as stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury
- Autoimmune and systemic disorders including Hashimoto Thyroiditis, Crohn's Disease, ulcerous colitis, type I diabetes mellitus, systemic lupus erythematosus
- Malignancy unless in remission for more than 10 years
- Instable psychiatric disorders including acute psychotic, 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, HIV
- Chronic use of antibiotics
- Recent use (less than 8 weeks) of immune-modulating drugs
- For healthy controls: subjective complaints of EDS/hypersomnia, ESS > 10, polysomnography with apnea index > 10/h or periodic leg movement syndrome index > 30/h, mean sleep latency < 12 min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Claudio L Bassetti
Bern, Switzerland, 3010
Actively Recruiting
Research Team
C
Claudio L Bassetti, Prof.
CONTACT
J
Jan Warncke, PhD
CONTACT
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
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