Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,200
- Locations
- 2
- Primary Endpoint
- Language
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 20 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Sleep study (Other)
Outcomes
Primary Outcomes
Language
Time Frame: 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.
Quality of life
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Sensoriality
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
- 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)