Clinical trial NCT04971850: Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Official title: Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep-disordered Breathing (SDB)
Keywords: Sleep-disordered breathing (SDB)
Poly(somno)graphy (P(S)G)
Cerebral oxygenation
Cyclic alternating pattern (CAP)
Psychological and neuropsychological tests
Screening questionnaires
Treatment of SDB
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Anxiety
timeFrame: The day after the P(S)G
measure: Depression
timeFrame: The day after the P(S)G
measure: Quality of life
timeFrame: The day after the P(S)G
measure: Sensoriality
timeFrame: The day after the P(S)G
measure: NEPSY-II memory evaluation
timeFrame: The day after the P(S)G
measure: Children Memory Scale
timeFrame: The day after the P(S)G
measure: Attention
timeFrame: The day after the P(S)G
measure: NEPSY-II score
timeFrame: The day after the P(S)G
measure: Trail Making test score
timeFrame: The day after the P(S)G
measure: KiTAP subtests score
timeFrame: The day after the P(S)G
measure: Behavior
timeFrame: The day after the P(S)G
measure: Griffiths-III score
timeFrame: The day after the P(S)G
measure: WPPSI-IV score
timeFrame: The day after the P(S)G
measure: WISC-V score
timeFrame: The day after the P(S)G
measure: Language
timeFrame: The day after the P(S)G
Secondary outcomes:
measure: Sleep disturbance
timeFrame: The day after baseline P(S)G
measure: 3D facial surface analysis
timeFrame: The day after baseline P(S)G
measure: 3D facial surface analysis
timeFrame: The day after baseline P(S)G
measure: 3D facial surface analysis
timeFrame: The day after baseline P(S)G
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Changing detection of respiratory events
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with clinical signs of SDB
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with pulse oximetry
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with sleep questionnaires
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with psychological and neuropsychological tests
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with psychological and neuropsychological tests
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Correlations with psychological and neuropsychological tests
timeFrame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery
measure: Alternative analysis
timeFrame: The day after baseline P(S)G
measure: Alternative analysis in (pre-)teens
timeFrame: The day after baseline P(S)G
measure: Alternative analysis
timeFrame: The day after baseline P(S)G
measure: Effect of treatment on Griffiths-III score
timeFrame: At one year
measure: Effect of treatment on WPPSI-IV score
timeFrame: At one year
measure: Effect of treatment on WISC-V score
timeFrame: At one year
measure: Effect of treatment
timeFrame: At one year
measure: Effect of treatment
timeFrame: At one year
measure: Effect of treatment on Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At one year
measure: Effect of treatment on Epworth sleepiness scale (ESS)
timeFrame: At one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte Fauroux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sonia Khirani, PhD
role: STUDY_DIRECTOR
References: