Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
- Conditions
- Sleep-disordered Breathing (SDB)
- Interventions
- Other: Sleep study
- Registration Number
- NCT04971850
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sleep-disordered breathing (SDB) Sleep study 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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 in (pre-)teens The day after baseline P(S)G Correlations between sleep stages obtained from PSG and sleep stages from a sleep headband.
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.
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 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.
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.
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
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.
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 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 mean cerebral oxygenation between baseline and 1 year following treatment.
Trial Locations
- Locations (1)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France