Cohort study on narcolepsy and hypersomnolence in Switzerland
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Insel Gruppe AG, University Hospital Bern · NCT04330963
This study looks at people with narcolepsy and excessive sleepiness to see how their conditions develop over time and to find possible signs that could help with diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 10 Years to 70 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT04330963 on ClinicalTrials.gov |
What this trial studies
The Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is an observational cohort study that aims to explore the clinical, electrophysiological, and biological biomarkers associated with narcolepsy and hypersomnolence disorders. This multi-center study will assess disease presentation and long-term progression in affected individuals, as well as include healthy controls for comparison. Participants will undergo routine electrophysiological assessments to gather data on their conditions. The study seeks to enhance understanding of these sleep disorders and identify potential biomarkers for diagnosis and treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals experiencing excessive daytime sleepiness or hypersomnia on a daily basis for at least one month, as well as healthy controls matched by age and gender.
Not a fit: Patients with conditions unrelated to hypersomnolence or narcolepsy, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for patients suffering from narcolepsy and hypersomnolence disorders.
How similar studies have performed: Other studies have explored similar conditions and biomarkers, but this specific cohort approach is relatively novel in the context of Swiss healthcare.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Claudio L Bassetti — Bern, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Claudio L Bassetti, Prof.
- Email: Claudio.Bassetti@insel.ch
- Phone: +41 31 63 2 30 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder