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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-20
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Sleep study

    Other intervention

    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.

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Sleep-disordered breathing (SDB)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The day after the P(S)G
2

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.

Time frame
The day after the P(S)G
3

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.

Time frame
The day after the P(S)G
4

Sensoriality

Sensoriality using the Sensory profile test. Atypical performance for a raw score \<122. Min value = 38. Max value = 190.

Time frame
The day after the P(S)G

Secondary outcomes

1

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.

Time frame
The day after baseline P(S)G
2

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.

Time frame
The day after baseline P(S)G
3

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.

Time frame
The day after baseline P(S)G
4

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.

Time frame
The day after baseline P(S)G

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator