Pediatric Cohort Study (COSACM)

• ClinicalTrials.gov Identifier: NCT04561427
• Recruitment Status: Recruiting
• First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Study Description

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.

Condition or disease	Intervention/treatment
Narcolepsy in Children	Other: Study of Sleep architecture in children with narcolepsy

Study Design

• Study Type: Observational
• Estimated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
• Actual Study Start Date: February 1, 2019
• Estimated Primary Completion Date: February 1, 2022
• Estimated Study Completion Date: February 1, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Sleep period (SP) evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
2. Total sleep time (TST) evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
3. Stage 1 duration evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
4. Stage 2 duration evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
5. Stage 3 duration evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
6. Stage 1 percentage evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
7. Stage 2 percentage evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
8. Stage 3 percentage evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
9. REM duration evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
   In minutes
10. REM percentage of TST evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage of TST
11. Sleep efficiency evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    TST / SP in percentage
12. Sleep latency evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes, first epoch of NREM or REM sleep
13. REM latency evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes, first epoch of REM sleep from sleep onset
14. Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes between sleep onset and sleep offset,
15. Micro-arousal index evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Number of event / hour
16. Arousal index evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
17. Leg movements index evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Number of event / hour
18. Apnea-hypopnea index evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Number of respiratory events / hour
19. Mean saturation during sleep evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
20. Minimal saturation during sleep evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
21. Duration of SaO2<90% evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage of total sleep time
22. Index of desaturation > 3% evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Number of event / hour
23. Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmHg
24. Maximal CO2 during REM sleep evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmHg
25. Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
26. Sleep latency evaluated during multiple sleep latency test (MSLT) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes
27. Stage 1 latency evaluated during multiple sleep latency test (MSLT) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes
28. REM latency evaluated during multiple sleep latency test (MSLT) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes
29. SOREM evaluated during multiple sleep latency test (MSLT) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In minutes
30. Power in frequency bands delta, alpha, gamma, theta evaluated during PSG [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
31. Mean Bedtime evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
32. Mean Wake up time evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
33. Mean Time in bed evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
34. Mean Total Sleep time evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
35. Mean Waking time evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
36. Mean Sleep period evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
37. Mean Sleep efficiency evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    In percentage, during week-end days and week days
38. Mean wake after sleep onset duration evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
39. Mean Sleep latency evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
40. Mean fragmentation index evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    In percentage, during week-end days and week days
41. Mean Immobile time evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    In minutes, during week-end days and week days
42. Mean Moving time evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    In minutes, during week-end days and week days
43. Mean Number of immobile phases evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
44. Mean Number of one minute immobility periods evaluated by actimetry [ Time Frame: During 15 days before the diagnostic' hospitalization ]
    during week-end days and week days
45. Intellectual Quotient evaluated by the WISC [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    by a neuropsychologist.
46. Attention evaluated by the BLAST [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    during neuropsychological evaluation
47. Insomnia severity evaluated by Insomnia Severity Index (ISI) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
48. Depressive feelings evaluated by the Children Depression Inventory (CDI) [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
49. Attention disorders symptoms evaluated by the Conners rating scale [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
50. Fatigue evaluated by the Fatigue scale [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
51. Estimated severity of the disease evaluated by the Severity scale [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
52. Sleepiness evaluated by the Epworth sleepiness scale for children [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
53. Sleepiness evaluated by the Karolinska scale [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
54. Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In pg/mL
55. Circadian typology evaluated by the Horne and Ostberg questionnaire [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
56. Body fat evaluated by DEXA [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
57. Lean mass evaluated by DEXA [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
58. Leptin evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In ng/ml
59. Total ghrelin evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
60. Acylated ghrelin evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In pg/mL
61. Non-acylated ghrelin ghrelin evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In pg/mL
62. Fastin blood sugar evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmol/L
63. Fasting insulin evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mUI/L,
64. Hba1C evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In percentage
65. TSH evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mUI/L
66. T3 evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In pmol/L
67. T4 evaluated by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In pmol/L
68. Total cholesterol by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmol/L
69. LDL by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmol/L
70. HDL by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmol/L
71. Triglycerides by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    In mmol/L
72. NFS by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
73. Ionogram by blood test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
74. Epstein Barr Virus antibodies by serology [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Positivity
75. Hepatitis B antibodies by serology [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Positivity
76. Streptococcus antibodies by serology [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Positivity
77. HLA evaluated by genotyping [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
    Presence of the known HLA factor of predisposition for narcolepsy,
78. Urinary prolactin evaluated by urine test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
79. Urinary sulfatoxy-melatonin evaluated by urine test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]
80. Urinary cortisol evaluated by urine test [ Time Frame: During the 72 hours of the diagnostic' hospitalization ]

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children or adolescents (0 to 18 years old)

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

Contacts and Locations

Contacts

Contact: Patricia Franco; 4.27.85.60.52 ext +33; patricia.franco@chu-lyon.fr

Contact: Aurore Guyon; 4.27.85.52.47 ext +33; aurore.guyon@chu-lyon.fr

Locations

France

: Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon; Recruiting

Lyon, France, 69500

Contact: Patricia Franco

Sponsors and Collaborators

Hospices Civils de Lyon

More Information

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04561427
• Other Study ID Numbers: COSACM_2020
• First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Narcolepsy; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders