Pediatric Cohort Study (COSACM)

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.

Study Overview

• Status: Unknown
• Conditions: Narcolepsy in Children
• Intervention / Treatment: Other: Study of Sleep architecture in children with narcolepsy

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Patricia Franco; Phone Number: +33 4.27.85.60.52; Email: patricia.franco@chu-lyon.fr
• Study Contact Backup: Name: Aurore Guyon; Phone Number: +33 4.27.85.52.47; Email: aurore.guyon@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69500
    • Recruiting
    • : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
    • Contact: Patricia Franco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children or adolescents (0 to 18 years old)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric Patients with narcolepsy; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: COSACM_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No