Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sleep period (SP) evaluated by polysomnography (PSG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 0 and 18 years old
- •Patients diagnosed with primary or secondary narcolepsy
- •From both gender
排除标准
- •Patients diagnosed with another sleep disorder
- •Healthy patients
- •Patients older than 18 years old
结局指标
主要结局
Sleep period (SP) evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 1 duration evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
REM percentage of TST evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage of TST
Sleep efficiency evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
TST / SP in percentage
Sleep latency evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes, first epoch of NREM or REM sleep
Stage 3 duration evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Total sleep time (TST) evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 2 duration evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Arousal index evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
Stage 1 percentage evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 2 percentage evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
REM duration evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 3 percentage evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Micro-arousal index evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
Leg movements index evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
REM latency evaluated by polysomnography (PSG)
时间窗: 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)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes between sleep onset and sleep offset,
Apnea-hypopnea index evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
Number of respiratory events / hour
Mean saturation during sleep evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
Minimal saturation during sleep evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
Duration of SaO2<90% evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage of total sleep time
Index of desaturation > 3% evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmHg
Maximal CO2 during REM sleep evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmHg
Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
Sleep latency evaluated during multiple sleep latency test (MSLT)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 1 latency evaluated during multiple sleep latency test (MSLT)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
REM latency evaluated during multiple sleep latency test (MSLT)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
SOREM evaluated during multiple sleep latency test (MSLT)
时间窗: During the 72 hours of the diagnostic' hospitalization
In minutes
Power in frequency bands delta, alpha, gamma, theta evaluated during PSG
时间窗: During the 72 hours of the diagnostic' hospitalization
Mean Bedtime evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Wake up time evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Total Sleep time evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Time in bed evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean wake after sleep onset duration evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Sleep latency evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Number of immobile phases evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Attention evaluated by the BLAST
时间窗: During the 72 hours of the diagnostic' hospitalization
during neuropsychological evaluation
Depressive feelings evaluated by the Children Depression Inventory (CDI)
时间窗: During the 72 hours of the diagnostic' hospitalization
Fatigue evaluated by the Fatigue scale
时间窗: During the 72 hours of the diagnostic' hospitalization
Total ghrelin evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
Non-acylated ghrelin ghrelin evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Fastin blood sugar evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmol/L
TSH evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mUI/L
HDL by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmol/L
Urinary prolactin evaluated by urine test
时间窗: During the 72 hours of the diagnostic' hospitalization
Mean Waking time evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Sleep period evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Attention disorders symptoms evaluated by the Conners rating scale
时间窗: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Epworth sleepiness scale for children
时间窗: During the 72 hours of the diagnostic' hospitalization
Circadian typology evaluated by the Horne and Ostberg questionnaire
时间窗: During the 72 hours of the diagnostic' hospitalization
Leptin evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In ng/ml
Mean Sleep efficiency evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
In percentage, during week-end days and week days
Mean fragmentation index evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
In percentage, during week-end days and week days
Mean Immobile time evaluated by actimetry
时间窗: During 15 days before the diagnostic' hospitalization
In minutes, during week-end days and week days
Mean Moving time evaluated by actimetry
时间窗: 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
时间窗: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Intellectual Quotient evaluated by the WISC
时间窗: During the 72 hours of the diagnostic' hospitalization
by a neuropsychologist.
Insomnia severity evaluated by Insomnia Severity Index (ISI)
时间窗: During the 72 hours of the diagnostic' hospitalization
Estimated severity of the disease evaluated by the Severity scale
时间窗: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Karolinska scale
时间窗: During the 72 hours of the diagnostic' hospitalization
Acylated ghrelin evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Fasting insulin evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mUI/L,
Hba1C evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
T4 evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In pmol/L
Triglycerides by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmol/L
Epstein Barr Virus antibodies by serology
时间窗: During the 72 hours of the diagnostic' hospitalization
Positivity
Streptococcus antibodies by serology
时间窗: During the 72 hours of the diagnostic' hospitalization
Positivity
Urinary cortisol evaluated by urine test
时间窗: During the 72 hours of the diagnostic' hospitalization
Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction
时间窗: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Body fat evaluated by DEXA
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
Lean mass evaluated by DEXA
时间窗: During the 72 hours of the diagnostic' hospitalization
In percentage
Total cholesterol by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmol/L
LDL by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In mmol/L
NFS by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
Ionogram by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
HLA evaluated by genotyping
时间窗: 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
时间窗: During the 72 hours of the diagnostic' hospitalization
T3 evaluated by blood test
时间窗: During the 72 hours of the diagnostic' hospitalization
In pmol/L
Hepatitis B antibodies by serology
时间窗: During the 72 hours of the diagnostic' hospitalization
Positivity
次要结局
未报告次要终点