Status:
RECRUITING
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Klinik Barmelweid
Zentrum für Schlafmedizin Basel
Conditions:
Narcolepsy
Idiopathic Hypersomnia
Eligibility:
All Genders
10-70 years
Brief 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.
Detailed Description
An exploratory prospective, national, multi-center cohort study on clinical, electrophysiological and biological biomarkers of disease presentation and course.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04330963
Start Date
January 6 2020
End Date
June 30 2026
Last Update
April 20 2023
Active Locations (1)
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1
Claudio L Bassetti
Bern, Switzerland, 3010