An observational study in Narcolepsy in Children, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-23.
Sponsored by Hospices Civils de Lyon · Observational
Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. These symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. The physiopathology of this rare disease still needs investigations. Since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.
149 studies on the registry are indexed under Narcolepsy; 33 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 34 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children or adolescents (0 to 18 years old)
Exclusion Criteria:
* Patients between 0 and 18 years old * Patients diagnosed with primary or secondary narcolepsy * From both gender
Other: Study of Sleep architecture in children with narcolepsy
Evaluate the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children
Sleep period (SP) evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Total sleep time (TST) evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 1 duration evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 2 duration evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 3 duration evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 1 percentage evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 2 percentage evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 3 percentage evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
REM duration evaluated by polysomnography (PSG)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
REM percentage of TST evaluated by polysomnography (PSG)
In percentage of TST
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleep efficiency evaluated by polysomnography (PSG)
TST / SP in percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleep latency evaluated by polysomnography (PSG)
In minutes, first epoch of NREM or REM sleep
Time frame: During the 72 hours of the diagnostic' hospitalization
REM latency evaluated by polysomnography (PSG)
In minutes, first epoch of REM sleep from sleep onset
Time frame: During the 72 hours of the diagnostic' hospitalization
Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG)
In minutes between sleep onset and sleep offset,
Time frame: During the 72 hours of the diagnostic' hospitalization
Micro-arousal index evaluated by polysomnography (PSG)
Number of event / hour
Time frame: During the 72 hours of the diagnostic' hospitalization
Arousal index evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Leg movements index evaluated by polysomnography (PSG)
Number of event / hour
Time frame: During the 72 hours of the diagnostic' hospitalization
Apnea-hypopnea index evaluated by polysomnography (PSG)
Number of respiratory events / hour
Time frame: During the 72 hours of the diagnostic' hospitalization
Mean saturation during sleep evaluated by polysomnography (PSG)
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Minimal saturation during sleep evaluated by polysomnography (PSG)
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Duration of SaO2<90% evaluated by polysomnography (PSG)
In percentage of total sleep time
Time frame: During the 72 hours of the diagnostic' hospitalization
Index of desaturation > 3% evaluated by polysomnography (PSG)
Number of event / hour
Time frame: During the 72 hours of the diagnostic' hospitalization
Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)
In mmHg
Time frame: During the 72 hours of the diagnostic' hospitalization
Maximal CO2 during REM sleep evaluated by polysomnography (PSG)
In mmHg
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleep latency evaluated during multiple sleep latency test (MSLT)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Stage 1 latency evaluated during multiple sleep latency test (MSLT)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
REM latency evaluated during multiple sleep latency test (MSLT)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
SOREM evaluated during multiple sleep latency test (MSLT)
In minutes
Time frame: During the 72 hours of the diagnostic' hospitalization
Power in frequency bands delta, alpha, gamma, theta evaluated during PSG
Time frame: During the 72 hours of the diagnostic' hospitalization
Mean Bedtime evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Wake up time evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Time in bed evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Total Sleep time evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Waking time evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Sleep period evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Sleep efficiency evaluated by actimetry
In percentage, during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean wake after sleep onset duration evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Sleep latency evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean fragmentation index evaluated by actimetry
In percentage, during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Immobile time evaluated by actimetry
In minutes, during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Moving time evaluated by actimetry
In minutes, during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Number of immobile phases evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Mean Number of one minute immobility periods evaluated by actimetry
during week-end days and week days
Time frame: During 15 days before the diagnostic' hospitalization
Intellectual Quotient evaluated by the WISC
by a neuropsychologist.
Time frame: During the 72 hours of the diagnostic' hospitalization
Attention evaluated by the BLAST
during neuropsychological evaluation
Time frame: During the 72 hours of the diagnostic' hospitalization
Insomnia severity evaluated by Insomnia Severity Index (ISI)
Time frame: During the 72 hours of the diagnostic' hospitalization
Depressive feelings evaluated by the Children Depression Inventory (CDI)
Time frame: During the 72 hours of the diagnostic' hospitalization
Attention disorders symptoms evaluated by the Conners rating scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Fatigue evaluated by the Fatigue scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Estimated severity of the disease evaluated by the Severity scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Epworth sleepiness scale for children
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Karolinska scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction
In pg/mL
Time frame: During the 72 hours of the diagnostic' hospitalization
Circadian typology evaluated by the Horne and Ostberg questionnaire
Time frame: During the 72 hours of the diagnostic' hospitalization
Body fat evaluated by DEXA
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Lean mass evaluated by DEXA
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
Leptin evaluated by blood test
In ng/ml
Time frame: During the 72 hours of the diagnostic' hospitalization
Total ghrelin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Acylated ghrelin evaluated by blood test
In pg/mL
Time frame: During the 72 hours of the diagnostic' hospitalization
Non-acylated ghrelin ghrelin evaluated by blood test
In pg/mL
Time frame: During the 72 hours of the diagnostic' hospitalization
Fastin blood sugar evaluated by blood test
In mmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
Fasting insulin evaluated by blood test
In mUI/L,
Time frame: During the 72 hours of the diagnostic' hospitalization
Hba1C evaluated by blood test
In percentage
Time frame: During the 72 hours of the diagnostic' hospitalization
TSH evaluated by blood test
In mUI/L
Time frame: During the 72 hours of the diagnostic' hospitalization
T3 evaluated by blood test
In pmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
T4 evaluated by blood test
In pmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
Total cholesterol by blood test
In mmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
LDL by blood test
In mmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
HDL by blood test
In mmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
Triglycerides by blood test
In mmol/L
Time frame: During the 72 hours of the diagnostic' hospitalization
NFS by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Ionogram by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Epstein Barr Virus antibodies by serology
Positivity
Time frame: During the 72 hours of the diagnostic' hospitalization
Hepatitis B antibodies by serology
Positivity
Time frame: During the 72 hours of the diagnostic' hospitalization
Streptococcus antibodies by serology
Positivity
Time frame: During the 72 hours of the diagnostic' hospitalization
HLA evaluated by genotyping
Presence of the known HLA factor of predisposition for narcolepsy,
Time frame: During the 72 hours of the diagnostic' hospitalization
Urinary prolactin evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
Urinary sulfatoxy-melatonin evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
Urinary cortisol evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon