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Pediatric Cohort Study (COSACM)

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

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561427


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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders