Clinical trial NCT04561427: Pediatric Cohort Study
Official title: Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Narcolepsy in Children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children or adolescents (0 to 18 years old)

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep period (SP) evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Total sleep time (TST) evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 1 duration evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 2 duration evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 3 duration evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 1 percentage evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 2 percentage evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 3 percentage evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: REM duration evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: REM percentage of TST evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleep efficiency evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleep latency evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: REM latency evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Micro-arousal index evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Arousal index evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Leg movements index evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Apnea-hypopnea index evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Mean saturation during sleep evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Minimal saturation during sleep evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Duration of SaO2<90% evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Index of desaturation > 3% evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Maximal CO2 during REM sleep evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleep latency evaluated during multiple sleep latency test (MSLT)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Stage 1 latency evaluated during multiple sleep latency test (MSLT)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: REM latency evaluated during multiple sleep latency test (MSLT)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: SOREM evaluated during multiple sleep latency test (MSLT)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Power in frequency bands delta, alpha, gamma, theta evaluated during PSG
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Mean Bedtime evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Wake up time evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Time in bed evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Total Sleep time evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Waking time evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Sleep period evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Sleep efficiency evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean wake after sleep onset duration evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Sleep latency evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean fragmentation index evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Immobile time evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Moving time evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Number of immobile phases evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Mean Number of one minute immobility periods evaluated by actimetry
timeFrame: During 15 days before the diagnostic' hospitalization
measure: Intellectual Quotient evaluated by the WISC
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Attention evaluated by the BLAST
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Insomnia severity evaluated by Insomnia Severity Index (ISI)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Depressive feelings evaluated by the Children Depression Inventory (CDI)
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Attention disorders symptoms evaluated by the Conners rating scale
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Fatigue evaluated by the Fatigue scale
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Estimated severity of the disease evaluated by the Severity scale
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleepiness evaluated by the Epworth sleepiness scale for children
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Sleepiness evaluated by the Karolinska scale
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Circadian typology evaluated by the Horne and Ostberg questionnaire
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Body fat evaluated by DEXA
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Lean mass evaluated by DEXA
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Leptin evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Total ghrelin evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Acylated ghrelin evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Non-acylated ghrelin ghrelin evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Fastin blood sugar evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Fasting insulin evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Hba1C evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: TSH evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: T3 evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: T4 evaluated by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Total cholesterol by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: LDL by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: HDL by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Triglycerides by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: NFS by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Ionogram by blood test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Epstein Barr Virus antibodies by serology
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Hepatitis B antibodies by serology
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Streptococcus antibodies by serology
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: HLA evaluated by genotyping
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Urinary prolactin evaluated by urine test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Urinary sulfatoxy-melatonin evaluated by urine test
timeFrame: During the 72 hours of the diagnostic' hospitalization
measure: Urinary cortisol evaluated by urine test
timeFrame: During the 72 hours of the diagnostic' hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Study officials:
References: