Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of life
时间窗: 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.
Griffiths-III score
时间窗: The day after the P(S)G
Neurodevelopment evaluation using the Griffiths-III. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Depression
时间窗: 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.
Trail Making test score
时间窗: 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.
WPPSI-IV score
时间窗: The day after the P(S)G
Neurodevelopment evaluation using the WPPSI-IV. Mean normal score is 100 ± 15. Abnormal for a score \<70.
NEPSY-II memory evaluation
时间窗: 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.
NEPSY-II score
时间窗: 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.
KiTAP subtests score
时间窗: 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.
WISC-V score
时间窗: The day after the P(S)G
Neurodevelopment evaluation using the WISC-V. Mean normal score is 100 ± 15. Abnormal for a score \<70.
Anxiety
时间窗: 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.
Language
时间窗: 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.
Sensoriality
时间窗: 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.
Children Memory Scale
时间窗: 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
时间窗: 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.
Behavior
时间窗: 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.
次要结局
- Alternative analysis in (pre-)teens(The day after baseline P(S)G)
- Sleep disturbance(The day after baseline P(S)G)
- Effect of treatment on WPPSI-IV score(At one year)
- Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)(At one year)
- Effect of treatment on Epworth sleepiness scale (ESS)(At one year)
- Effect of treatment on Griffiths-III score(At one year)
- Effect of treatment on WISC-V score(At one year)
- Correlations with pulse oximetry(The day after baseline P(S)G and 1 year after the intervention/procedure/surgery)
- Correlations with clinical signs of SDB(The day after baseline P(S)G and 1 year after the intervention/procedure/surgery)
- Correlations with sleep questionnaires(The day after baseline P(S)G and 1 year after the intervention/procedure/surgery)
- Correlations with psychological and neuropsychological tests(The day after baseline P(S)G and 1 year after the intervention/procedure/surgery)
- Alternative analysis(The day after baseline P(S)G)
- Effect of treatment(At one year)
- 3D facial surface analysis(The day after baseline P(S)G)
- Changing detection of respiratory events(The day after baseline P(S)G and 1 year after the intervention/procedure/surgery)