Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

Sleep study: Procedures added by research during PSG : * SDB screening questionnaires * Electromyography (EMG) of accessory and abdominal muscles * Cerebral oxygenation * Mandibular movements * Sleep headband (pre-teens and teens) or other connected device * Automatic PSG analyzes * Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG.

Study summary

One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB.

The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

Eligibility

Primary outcome measure(s)

• Anxiety — The day after the P(S)G
  Anxiety questionnaire using the Revised Children's Manifest Anxiety Scale (RCMAS), with an anxiety being defined by a total T-score ≥60. Mean normal value of T-score is 50 ± 10.
• Depression — The day after the P(S)G
  Depression questionnaire using the Multiscore Depression Inventory for Children (MDI-C), with an abnormal score being defined by a T-score ≥70. Mean normal value of T-score is 50 ± 10.
• Quality of life — The day after the P(S)G
  Quality of life questionnaire using the Pediatric Quality of Life Inventory (PedsQL). The higher the score, the better the quality of life. Min value = 0. Max value = 100.
• Sensoriality — The day after the P(S)G
  Sensoriality using the Sensory profile test. Atypical performance for a raw score \<122. Min value = 38. Max value = 190.
• NEPSY-II memory evaluation — The day after the P(S)G
  Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score \<4.
• Children Memory Scale — The day after the P(S)G
  Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score \<4.
• Attention — The day after the P(S)G
  Attention evaluation using the TAP test. Abnormal for a T-score \<30. Mean normal value of T-score is 50 ± 10.
• NEPSY-II score — The day after the P(S)G
  Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score \<4.
• Trail Making test score — The day after the P(S)G
  Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score \<4.
• KiTAP subtests score — The day after the P(S)G
  Executive function evaluation using the KiTAP subtests. Abnormal T-score \<30, with mean normal value of T-score is 50 ± 10.
• Behavior — The day after the P(S)G
  Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score \>65. Mean normal value of T-score is 50 ± 10.
• Griffiths-III score — The day after the P(S)G
  Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score \<70.
• WPPSI-IV score — The day after the P(S)G
  Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score \<70.
• WISC-V score — The day after the P(S)G
  Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score \<70.
• Language — The day after the P(S)G
  Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score \<70.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France