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.
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. In addition, the clinical impact of SDB and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective. Finally, the validation of simplified tools could optimize and simplify the detection of SDB in children and young adults. Patients scheduled to perform a diagnostic PSG for routine clinical care will have additional recordings and questionnaires as part of the study. The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,200
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.
Hôpital Necker-Enfants Malades
Paris, France
RECRUITINGAnxiety
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
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
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
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
NEPSY-II memory evaluation
Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score \<4.
Time frame: The day after the P(S)G
Children Memory Scale
Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score \<4.
Time frame: The day after the P(S)G
Attention
Attention evaluation using the TAP test. Abnormal for a T-score \<30. Mean normal value of T-score is 50 ± 10.
Time frame: The day after the P(S)G
NEPSY-II score
Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score \<4.
Time frame: The day after the P(S)G
Trail Making test score
Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score \<4.
Time frame: The day after the P(S)G
KiTAP subtests score
Executive function evaluation using the KiTAP subtests. Abnormal T-score \<30, with mean normal value of T-score is 50 ± 10.
Time frame: The day after the P(S)G
Behavior
Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score \>65. Mean normal value of T-score is 50 ± 10.
Time frame: The day after the P(S)G
Griffiths-III score
Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: The day after the P(S)G
WPPSI-IV score
Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: The day after the P(S)G
WISC-V score
Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: The day after the P(S)G
Language
Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: The day after the P(S)G
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
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
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
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
Changing detection of respiratory events
Comparison between the apnea-hypopnea index (AHI) obtained from the P(S)G and the AHI calculated using respiratory muscle EMG
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account hypoventilation and flow limitation
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events
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Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Changing detection of respiratory events
Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and respiratory muscles power by EMG.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with clinical signs of SDB
Correlation between clinical signs by questionnaire and the type of CAP by EEG.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and respiratory muscles power by EMG.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and pulse transit time analysis.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with pulse oximetry
Correlation between pulse oximetry and the type of CAP.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and respiratory muscles EMG.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and pulse transit time analysis.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and cerebral oxygenation analysis.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with sleep questionnaires
Correlation between sleep questionnaires and the type of CAP.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests
Correlation between psychological and neuropsychological scores and the different calculated AHI.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests
Correlation between psychological and neuropsychological scores and the types of CAP.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Correlations with psychological and neuropsychological tests
Correlation between psychological and mean nocturnal cerebral oxygenation.
Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
Alternative analysis
Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography.
Time frame: The day after baseline P(S)G
Alternative analysis in (pre-)teens
Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.
Time frame: The day after baseline P(S)G
Alternative analysis
Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.
Time frame: The day after baseline P(S)G
Effect of treatment on Griffiths-III score
Comparison of neurodevelopment evaluation using the Griffiths-III between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: At one year
Effect of treatment on WPPSI-IV score
Comparison of neurodevelopment evaluation using the WPPSI-IV between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: At one year
Effect of treatment on WISC-V score
Comparison of neurodevelopment evaluation using the WISC-V between baseline and 1 year following treatment for severe or moderate-to-severe (pubescent patient) obstructive sleep apnea. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Time frame: At one year
Effect of treatment
Comparison of the percentage of types of CAP between baseline and 1 year following treatment.
Time frame: At one year
Effect of treatment
Comparison of mean cerebral oxygenation between baseline and 1 year following treatment.
Time frame: At one year
Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)
Comparison of PSQI scores between baseline and 1 year following treatment. PSQI max score = 21. Threshold values for the PSQI scale: 0-4: Good, 5-8: Moderate, \>9: Bad sleep quality.
Time frame: At one year
Effect of treatment on Epworth sleepiness scale (ESS)
Comparison of ESS scores between baseline and 1 year following treatment. ESS max score = 33. Threshold values for the ESS scale: \<8: No, 9-14: Moderate, \>15: Severe sleepiness.
Time frame: At one year