Sleep-disordered Breathing (SDB)
Conditions
Keywords
Sleep-disordered breathing (SDB), Poly(somno)graphy (P(S)G), Cerebral oxygenation, Cyclic alternating pattern (CAP), Psychological and neuropsychological tests, Screening questionnaires, Treatment of SDB
Brief 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.
Detailed description
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.
Interventions
OTHERSleep 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* No social insurance * Significant psychomotor retardation * Cooperation not possible * Significant agitation * Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection) * Patient under guardianship/curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbance | The day after baseline P(S)G | 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 | The day after baseline P(S)G | 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. |
| Changing detection of respiratory events | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | Comparison between the apnea-hypopnea index (AHI) obtained from the P(S)G and the AHI calculated using respiratory muscle EMG |
| Correlations with clinical signs of SDB | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | Correlation between clinical signs by questionnaire and respiratory muscles power by EMG. |
| Correlations with pulse oximetry | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | Correlation between pulse oximetry and respiratory muscles power by EMG. |
| Correlations with sleep questionnaires | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | Correlation between sleep questionnaires and respiratory muscles EMG. |
| Correlations with psychological and neuropsychological tests | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | Correlation between psychological and neuropsychological scores and the different calculated AHI. |
| Alternative analysis | The day after baseline P(S)G | Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography. |
| Alternative analysis in (pre-)teens | The day after baseline P(S)G | Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband. |
| Effect of treatment on Griffiths-III score | At one year | 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. |
| Effect of treatment on WPPSI-IV score | At one year | 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. |
| Effect of treatment on WISC-V score | At one year | 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. |
| Effect of treatment | At one year | Comparison of the percentage of types of CAP between baseline and 1 year following treatment. |
| Effect of treatment on Pittsburgh Sleep Quality Index (PSQI) | At one year | 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. |
| Effect of treatment on Epworth sleepiness scale (ESS) | At one year | 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. |
Countries
France
Contacts
CONTACTBrigitte Fauroux, MD, PhD
CONTACTHélène Morel
PRINCIPAL_INVESTIGATORBrigitte Fauroux, MD, PhD
Assistance Publique - Hôpitaux de Paris
STUDY_DIRECTORSonia Khirani, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed