TRSPed: Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sleep-disordered breathing (SDB) Patients aged 1 to 20 years old with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study for their clinical care. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 3D facial surface analysis [The day after baseline P(S)G]
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 [The day after baseline P(S)G]
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.
- 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
- Changing detection of respiratory events [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account hypoventilation and flow limitation
- Changing detection of respiratory events [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude
- Changing detection of respiratory events [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time
- Changing detection of respiratory events [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements
- Changing detection of respiratory events [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations
- 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 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 hypoventilation and flow limitation scores by P(S)G.
- 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 autonomic arousals using pulse wave amplitude by pulse oximetry.
- 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 pulse transit time analysis by ECG.
- 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 mandibular movement analysis by non-invasive magnetic distance sensors.
- 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 cerebral oxygenation analysis by near-infrared spectroscopy.
- 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 the type of CAP by EEG.
- 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 pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G.
- Correlations with pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude.
- Correlations with pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and pulse transit time analysis.
- Correlations with pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors.
- Correlations with pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy.
- Correlations with pulse oximetry [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between pulse oximetry and the type of CAP.
- 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 sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G.
- Correlations with sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude.
- Correlations with sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and pulse transit time analysis.
- Correlations with sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors.
- Correlations with sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and cerebral oxygenation analysis.
- Correlations with sleep questionnaires [The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Correlation between sleep questionnaires and the type of CAP.
- 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.
- 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 types of CAP.
- 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 mean nocturnal cerebral oxygenation.
- 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.
- Alternative analysis [The day after baseline P(S)G]
Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis.
- 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 [At one year]
Comparison of mean cerebral oxygenation 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.
Eligibility Criteria
Criteria
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:
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No social insurance
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Significant psychomotor retardation
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Cooperation not possible
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Significant agitation
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Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)
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Patient under guardianship/curatorship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Necker-Enfants Malades | Paris | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Study Director: Sonia Khirani, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP210042
- 2020-A03083-36