Narcolepsy in Children Clinical Trial
— COSACMOfficial title:
Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | February 1, 2022 |
| Est. primary completion date | February 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sleep period (SP) evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Total sleep time (TST) evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 1 duration evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 2 duration evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 3 duration evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 1 percentage evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 2 percentage evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 3 percentage evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | REM duration evaluated by polysomnography (PSG) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | REM percentage of TST evaluated by polysomnography (PSG) | In percentage of TST | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Sleep efficiency evaluated by polysomnography (PSG) | TST / SP in percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Sleep latency evaluated by polysomnography (PSG) | In minutes, first epoch of NREM or REM sleep | During the 72 hours of the diagnostic' hospitalization | |
| Primary | REM latency evaluated by polysomnography (PSG) | In minutes, first epoch of REM sleep from sleep onset | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG) | In minutes between sleep onset and sleep offset, | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Micro-arousal index evaluated by polysomnography (PSG) | Number of event / hour | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Arousal index evaluated by polysomnography (PSG) | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Leg movements index evaluated by polysomnography (PSG) | Number of event / hour | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Apnea-hypopnea index evaluated by polysomnography (PSG) | Number of respiratory events / hour | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Mean saturation during sleep evaluated by polysomnography (PSG) | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Minimal saturation during sleep evaluated by polysomnography (PSG) | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Duration of SaO2<90% evaluated by polysomnography (PSG) | In percentage of total sleep time | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Index of desaturation > 3% evaluated by polysomnography (PSG) | Number of event / hour | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG) | In mmHg | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Maximal CO2 during REM sleep evaluated by polysomnography (PSG) | In mmHg | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG) | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Sleep latency evaluated during multiple sleep latency test (MSLT) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Stage 1 latency evaluated during multiple sleep latency test (MSLT) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | REM latency evaluated during multiple sleep latency test (MSLT) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | SOREM evaluated during multiple sleep latency test (MSLT) | In minutes | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Power in frequency bands delta, alpha, gamma, theta evaluated during PSG | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Mean Bedtime evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Wake up time evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Time in bed evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Total Sleep time evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Waking time evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Sleep period evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Sleep efficiency evaluated by actimetry | In percentage, during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean wake after sleep onset duration evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Sleep latency evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean fragmentation index evaluated by actimetry | In percentage, during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Immobile time evaluated by actimetry | In minutes, during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Moving time evaluated by actimetry | In minutes, during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Number of immobile phases evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Mean Number of one minute immobility periods evaluated by actimetry | during week-end days and week days | During 15 days before the diagnostic' hospitalization | |
| Primary | Intellectual Quotient evaluated by the WISC | by a neuropsychologist. | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Attention evaluated by the BLAST | during neuropsychological evaluation | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Insomnia severity evaluated by Insomnia Severity Index (ISI) | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Depressive feelings evaluated by the Children Depression Inventory (CDI) | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Attention disorders symptoms evaluated by the Conners rating scale | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Fatigue evaluated by the Fatigue scale | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Estimated severity of the disease evaluated by the Severity scale | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Sleepiness evaluated by the Epworth sleepiness scale for children | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Sleepiness evaluated by the Karolinska scale | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction | In pg/mL | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Circadian typology evaluated by the Horne and Ostberg questionnaire | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Body fat evaluated by DEXA | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Lean mass evaluated by DEXA | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Leptin evaluated by blood test | In ng/ml | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Total ghrelin evaluated by blood test | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Acylated ghrelin evaluated by blood test | In pg/mL | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Non-acylated ghrelin ghrelin evaluated by blood test | In pg/mL | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Fastin blood sugar evaluated by blood test | In mmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Fasting insulin evaluated by blood test | In mUI/L, | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Hba1C evaluated by blood test | In percentage | During the 72 hours of the diagnostic' hospitalization | |
| Primary | TSH evaluated by blood test | In mUI/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | T3 evaluated by blood test | In pmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | T4 evaluated by blood test | In pmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Total cholesterol by blood test | In mmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | LDL by blood test | In mmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | HDL by blood test | In mmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Triglycerides by blood test | In mmol/L | During the 72 hours of the diagnostic' hospitalization | |
| Primary | NFS by blood test | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Ionogram by blood test | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Epstein Barr Virus antibodies by serology | Positivity | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Hepatitis B antibodies by serology | Positivity | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Streptococcus antibodies by serology | Positivity | During the 72 hours of the diagnostic' hospitalization | |
| Primary | HLA evaluated by genotyping | Presence of the known HLA factor of predisposition for narcolepsy, | During the 72 hours of the diagnostic' hospitalization | |
| Primary | Urinary prolactin evaluated by urine test | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Urinary sulfatoxy-melatonin evaluated by urine test | During the 72 hours of the diagnostic' hospitalization | ||
| Primary | Urinary cortisol evaluated by urine test | During the 72 hours of the diagnostic' hospitalization |