international Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (iSPHYNCS): Dutch participatio

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

All participants:
- Age 16-70 years
- Ability and consent to undergo electrophysiological routine assessment
- Ability to give informed consent

Patients:
- Subjective complaints of excessive daytime sleepiness (EDS) and/or
hypersomnolence (H) as defined in the protocol
- EDS and/or H present daily or almost daily for at least 1 month prior to the
consultation

Healthy Controls:
- Proportionally age and gender matched healthy subjects

Exclusion Criteria

All participants:
- Chronic infectious diseases (such as Hepatitis B/C, HIV)
- Chronic use of antibiotics
- Recent use (over 8 weeks) of immune-modulating drugs

Patients:
- The following disorders/conditions that on clinical grounds are considered to
be the cause of EDS/H:
-- Other sleep disorders
-- Other neurological disorders
-- (Auto-)immune and systemic disorders
-- Malignancy (except: Status in Remission for over 10 years)
-- Instable psychiatric disorder
-- Active infectious disease at screening
-- Permanent medications/drugs
- Sleep disordered breathing (SDB): Presence of clinically significant and
untreated obstructive (OSA) or central sleep apnea (CSA) as determined by the
investigator or documented previously; or documentation of one of the
following:
-- Apnea index (AI) over10 if on OSA treatment or untreated; or
-- Clinically significant hypoventilation; or
-- Noncompliance with primary OSA/PAP therapy in case of clinically
significant OSA
-- except if NTI has been diagnosed including decreased or missing CSF
hypocretin

Healthy Controls:
- Subjective complaints of EDS and/or H as defined in the protocol
- Epworth Sleepines Scale (ESS) over 10
- Polysomnography (PSG) with apnea index (AI) over10/h and/or periodic leg
movement series (PLMS) Index over 30/h
- SDB: Presence of clinically significant and untreated OSA or central sleep
apnea (CSA) as determined by the investigator or documented previously; or
documentation of one of the following:
-- Apnea index (AI) over 10 if on OSA treatment or untreated; or
-- Clinically significant hypoventilation; or
-- Noncompliance with primary OSA/PAP therapy

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are clinical: the proportion of subjects with diagnosis<br /><br>of NT1 or other CDH diagnoses at follow up. Results from this study are<br /><br>expected to substantially improve (and revise) diagnostic criteria for NBL,<br /><br>which may result in identification of new treatment targets/strategies.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are biological determinants and biomarkers: the<br /><br>proportion of patients with autoreactive T-cell clones in NT1 and in some NBL<br /><br>subjects but not in controls, and the intestinal microbiome of NT1 and NBL in<br /><br>comparison to controls. The tertiary endpoints are Electrophysiological<br /><br>biomarkers and questionnaire outcomes for NT1 and NBL in comparison to<br /><br>controls. </p><br>