Mass cytometry-based analysis of the composition of the immune system in peripheral blood and cerebrospinal fluid in narcolepsy

Completed

Conditions: narcolepsy
sleep disorders
10003816
10002252
10040998

Registration Number: NL-OMON45374

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Diagnosed with narcolepsy type 1 according to ICSD-3 criteria (international criteria for sleep disorders, third edition)
Symptom onset < 1 year before inclusion
>= 12 years (patient), >= 18 years (control)

Exclusion Criteria

Patients and healthy controls:
Recent use (< 8 weeks) of immune-modulating drugs;
Active infection at screening;
Other primary sleep-wake disorders (such as narcolepsy type 2, idiopathic hypersomnia, obstructive sleep apnea syndrome);
Malignancy;
Chronic use of antibiotics;
Chronic infectious diseases (such as Hepatitis B/C, HIV);
(Auto-)immune disorders (such as multiple sclerosis, Hashimoto thyreoïditis, Crohn*s disease, diabetes mellitus type 1, systemic lupus erythematodes).;Healthy controls:
Excessive daytime sleepiness (Epworth Sleepiness Scale >=12).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Which immune cell populations are significantly different in peripheral blood<br /><br>of type 1 narcolepsy patients compared with healthy controls using mass<br /><br>cytometry and an antibody panel consisting of 36 cell surface markers?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Is the specific immune system composition in peripheral blood in narcolepsy<br /><br>type 1 reflected in CSF, using flow cytometryand cerebrospinal fluid of<br /><br>narcolepsy patients?</p><br>