About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study
Written informed consent
Disqualifiers
No social insurance
Significant psychomotor retardation
Cooperation not possible
Significant agitation
Trial design
Single group
Treatments tested in this trial
Sleep study
Other interventionProcedures 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.
Treatment groups
Trial outcomes
Primary outcomes
Anxiety
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
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
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
Sensoriality using the Sensory profile test. Atypical performance for a raw score \<122. Min value = 38. Max value = 190.
Secondary outcomes
Sleep disturbance
Score of the sleep disturbance scale for children (SDSC) to detect the presence and severity of SDB Children \< 4 years old: Min value 3, max value 15. Abnormal if score \>4. Children \> 4 years old: Min value 5, max value 25. Abnormal if score \>12.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of linear distances between 25 pairs of craniofacial landmarks, defined as direct Euclidean distance (in mm) between the two points.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of geodesic distances between 25 pairs of craniofacial landmarks, defined as the shortest distance (in mm) between two points when following the contour of the face/skin.
3D facial surface analysis
Geometric morphometric approach based on 3D facial surface analysis of angular measurements between 25 pairs of craniofacial landmarks, defined as the angles (in degree) between sets of three landmarks.
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator