Pediatric Cohort Study

• Conditions: Narcolepsy in Children
• Interventions: Other: Study of Sleep architecture in children with narcolepsy

• Registration Number: NCT04561427
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients between 0 and 18 years old
• Patients diagnosed with primary or secondary narcolepsy
• From both gender

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Exclusion Criteria

• Patients diagnosed with another sleep disorder
• Healthy patients
• Patients older than 18 years old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Patients with narcolepsy	Study of Sleep architecture in children with narcolepsy	* Patients between 0 and 18 years old * Patients diagnosed with primary or secondary narcolepsy * From both gender

Primary Outcome Measures

Name	Time	Method
Sleep period (SP) evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 1 duration evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
REM percentage of TST evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In percentage of TST
Sleep efficiency evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	TST / SP in percentage
Sleep latency evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes, first epoch of NREM or REM sleep
Total sleep time (TST) evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 2 duration evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 3 duration evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 1 percentage evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 2 percentage evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
REM duration evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 3 percentage evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes
Micro-arousal index evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	Number of event / hour
Leg movements index evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	Number of event / hour
REM latency evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes, first epoch of REM sleep from sleep onset
Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In minutes between sleep onset and sleep offset,
Arousal index evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization
Apnea-hypopnea index evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	Number of respiratory events / hour
Mean saturation during sleep evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In percentage
Minimal saturation during sleep evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In percentage
Duration of SaO2<90% evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In percentage of total sleep time
Index of desaturation > 3% evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	Number of event / hour
Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In mmHg
Maximal CO2 during REM sleep evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In mmHg
Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)	During the 72 hours of the diagnostic' hospitalization	In percentage
Sleep latency evaluated during multiple sleep latency test (MSLT)	During the 72 hours of the diagnostic' hospitalization	In minutes
Stage 1 latency evaluated during multiple sleep latency test (MSLT)	During the 72 hours of the diagnostic' hospitalization	In minutes
REM latency evaluated during multiple sleep latency test (MSLT)	During the 72 hours of the diagnostic' hospitalization	In minutes
SOREM evaluated during multiple sleep latency test (MSLT)	During the 72 hours of the diagnostic' hospitalization	In minutes
Power in frequency bands delta, alpha, gamma, theta evaluated during PSG	During the 72 hours of the diagnostic' hospitalization
Mean Bedtime evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Wake up time evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Time in bed evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Total Sleep time evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean wake after sleep onset duration evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Sleep latency evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Number of immobile phases evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Attention evaluated by the BLAST	During the 72 hours of the diagnostic' hospitalization	during neuropsychological evaluation
Depressive feelings evaluated by the Children Depression Inventory (CDI)	During the 72 hours of the diagnostic' hospitalization
Fatigue evaluated by the Fatigue scale	During the 72 hours of the diagnostic' hospitalization
Total ghrelin evaluated by blood test	During the 72 hours of the diagnostic' hospitalization
Non-acylated ghrelin ghrelin evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In pg/mL
Fastin blood sugar evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In mmol/L
TSH evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In mUI/L
HDL by blood test	During the 72 hours of the diagnostic' hospitalization	In mmol/L
Urinary prolactin evaluated by urine test	During the 72 hours of the diagnostic' hospitalization
Mean Waking time evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Mean Sleep period evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Attention disorders symptoms evaluated by the Conners rating scale	During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Epworth sleepiness scale for children	During the 72 hours of the diagnostic' hospitalization
Circadian typology evaluated by the Horne and Ostberg questionnaire	During the 72 hours of the diagnostic' hospitalization
Leptin evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In ng/ml
Mean Sleep efficiency evaluated by actimetry	During 15 days before the diagnostic' hospitalization	In percentage, during week-end days and week days
Mean fragmentation index evaluated by actimetry	During 15 days before the diagnostic' hospitalization	In percentage, during week-end days and week days
Mean Immobile time evaluated by actimetry	During 15 days before the diagnostic' hospitalization	In minutes, during week-end days and week days
Mean Moving time evaluated by actimetry	During 15 days before the diagnostic' hospitalization	In minutes, during week-end days and week days
Mean Number of one minute immobility periods evaluated by actimetry	During 15 days before the diagnostic' hospitalization	during week-end days and week days
Intellectual Quotient evaluated by the WISC	During the 72 hours of the diagnostic' hospitalization	by a neuropsychologist.
Insomnia severity evaluated by Insomnia Severity Index (ISI)	During the 72 hours of the diagnostic' hospitalization
Estimated severity of the disease evaluated by the Severity scale	During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Karolinska scale	During the 72 hours of the diagnostic' hospitalization
Acylated ghrelin evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In pg/mL
Fasting insulin evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In mUI/L,
Hba1C evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In percentage
T4 evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In pmol/L
Triglycerides by blood test	During the 72 hours of the diagnostic' hospitalization	In mmol/L
Epstein Barr Virus antibodies by serology	During the 72 hours of the diagnostic' hospitalization	Positivity
Streptococcus antibodies by serology	During the 72 hours of the diagnostic' hospitalization	Positivity
Urinary cortisol evaluated by urine test	During the 72 hours of the diagnostic' hospitalization
Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction	During the 72 hours of the diagnostic' hospitalization	In pg/mL
Body fat evaluated by DEXA	During the 72 hours of the diagnostic' hospitalization	In percentage
Lean mass evaluated by DEXA	During the 72 hours of the diagnostic' hospitalization	In percentage
Total cholesterol by blood test	During the 72 hours of the diagnostic' hospitalization	In mmol/L
LDL by blood test	During the 72 hours of the diagnostic' hospitalization	In mmol/L
NFS by blood test	During the 72 hours of the diagnostic' hospitalization
Ionogram by blood test	During the 72 hours of the diagnostic' hospitalization
HLA evaluated by genotyping	During the 72 hours of the diagnostic' hospitalization	Presence of the known HLA factor of predisposition for narcolepsy,
Urinary sulfatoxy-melatonin evaluated by urine test	During the 72 hours of the diagnostic' hospitalization
T3 evaluated by blood test	During the 72 hours of the diagnostic' hospitalization	In pmol/L
Hepatitis B antibodies by serology	During the 72 hours of the diagnostic' hospitalization	Positivity

Trial Locations

Locations (1)

: Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France