Sleep-disordered Breathing (SDB) Clinical Trial
— TRSPedOfficial title:
Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
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.
| Status | Recruiting |
| Enrollment | 1200 |
| Est. completion date | February 2028 |
| Est. primary completion date | February 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 20 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker-Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | The day after the P(S)G | |
| Primary | 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. | The day after the P(S)G | |
| Primary | 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. | The day after the P(S)G | |
| Primary | Sensoriality | Sensoriality using the Sensory profile test. Atypical performance for a raw score <122. Min value = 38. Max value = 190. | The day after the P(S)G | |
| Primary | NEPSY-II memory evaluation | Memory evaluation using the NEPSY-II test. Mean normal score is 10 ± 3. Abnormal for a score <4. | The day after the P(S)G | |
| Primary | Children Memory Scale | Memory evaluation using the Children Memory Scale test. Mean normal score is 10 ± 3. Abnormal for a score <4. | The day after the P(S)G | |
| Primary | Attention | Attention evaluation using the TAP test. Abnormal for a T-score <30. Mean normal value of T-score is 50 ± 10. | The day after the P(S)G | |
| Primary | NEPSY-II score | Executive function evaluation using the NEPSY-II. Mean normal score tests is 10 ± 3, abnormal for a score <4. | The day after the P(S)G | |
| Primary | Trail Making test score | Executive function evaluation using the Trail Making test. Mean normal score is 10 ± 3, abnormal for a score <4. | The day after the P(S)G | |
| Primary | KiTAP subtests score | Executive function evaluation using the KiTAP subtests. Abnormal T-score <30, with mean normal value of T-score is 50 ± 10. | The day after the P(S)G | |
| Primary | Behavior | Behavior evaluation using the Child Behaviour Checklist (CBCL). Abnormal T-score >65. Mean normal value of T-score is 50 ± 10. | The day after the P(S)G | |
| Primary | Griffiths-III score | Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score <70. | The day after the P(S)G | |
| Primary | WPPSI-IV score | Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score <70. | The day after the P(S)G | |
| Primary | WISC-V score | Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score <70. | The day after the P(S)G | |
| Primary | Language | Language evaluation using the Griffiths-III test. Mean normal score is 100 ± 15. Abnormal for a score <70. | The day after the P(S)G | |
| Secondary | 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. | The day after baseline P(S)G | |
| Secondary | 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. | The day after baseline P(S)G | |
| Secondary | 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. | The day after baseline P(S)G | |
| Secondary | 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. | The day after baseline P(S)G | |
| Secondary | 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 | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | 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 | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Changing detection of respiratory events | Comparison between the AHI obtained from the P(S)G and the AHI calculated taking into account autonomic arousals using the pulse wave amplitude | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Changing detection of respiratory events | Comparison between the AHI obtained from the P(S)G and the AHI calculated using the pulse transit time | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Changing detection of respiratory events | Comparison between the AHI obtained from the P(S)G and the AHI calculated using mandibular movements | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Changing detection of respiratory events | Comparison between the AHI obtained from the P(S)G and the AHI calculated using cerebral oxygenation desaturations | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and respiratory muscles power by EMG. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and hypoventilation and flow limitation scores by P(S)G. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and autonomic arousals using pulse wave amplitude by pulse oximetry. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and pulse transit time analysis by ECG. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and mandibular movement analysis by non-invasive magnetic distance sensors. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and cerebral oxygenation analysis by near-infrared spectroscopy. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with clinical signs of SDB | Correlation between clinical signs by questionnaire and the type of CAP by EEG. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and respiratory muscles power by EMG. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and hypoventilation and flow limitation scores by P(S)G. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and autonomic arousals using pulse wave amplitude. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and pulse transit time analysis. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and mandibular movement analysis by non-invasive magnetic distance sensors. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and cerebral oxygenation analysis by near-infrared spectroscopy. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with pulse oximetry | Correlation between pulse oximetry and the type of CAP. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and respiratory muscles EMG. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and hypoventilation and flow limitation scores by P(S)G. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and autonomic arousals using pulse wave amplitude. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and pulse transit time analysis. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and mandibular movement analysis by non-invasive magnetic distance sensors. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and cerebral oxygenation analysis. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with sleep questionnaires | Correlation between sleep questionnaires and the type of CAP. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with psychological and neuropsychological tests | Correlation between psychological and neuropsychological scores and the different calculated AHI. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with psychological and neuropsychological tests | Correlation between psychological and neuropsychological scores and the types of CAP. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Correlations with psychological and neuropsychological tests | Correlation between psychological and mean nocturnal cerebral oxygenation. | The day after baseline P(S)G and 1 year after the intervention/procedure/surgery | |
| Secondary | Alternative analysis | Correlation between the AHI obtained from P(S)G and the AHI obtained using respiratory inductance plethysmography. | The day after baseline P(S)G | |
| Secondary | Alternative analysis in (pre-)teens | Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband. | The day after baseline P(S)G | |
| Secondary | Alternative analysis | Correlations between the sleep stages and AHI obtained from manual analysis of PSG and an automatic analysis. | The day after baseline P(S)G | |
| Secondary | 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. | At one year | |
| Secondary | 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. | At one year | |
| Secondary | 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. | At one year | |
| Secondary | Effect of treatment | Comparison of the percentage of types of CAP between baseline and 1 year following treatment. | At one year | |
| Secondary | Effect of treatment | Comparison of mean cerebral oxygenation between baseline and 1 year following treatment. | At one year | |
| Secondary | 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. | At one year | |
| Secondary | 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. | At one year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02877745 -
Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery
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