Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep study.
- Who it may be relevant to
- Registry conditions: Sleep-disordered Breathing (SDB). Basic parameters: 1 year — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Overview
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.
Interventions
- Other Sleep study
Procedures added by research during PSG : * SDB screening questionnaires * Electromyography (EMG) of accessory and abdominal muscles * Cerebral oxygenation * Mandibular movements * Sleep headband (pre-teens and teens) or other connected device * Automatic PSG analyzes * Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG.
Primary outcome measures
- Anxiety [Time frame: The day after the P(S)G]
- Depression [Time frame: The day after the P(S)G]
- Quality of life [Time frame: The day after the P(S)G]
- Sensoriality [Time frame: The day after the P(S)G]
- NEPSY-II memory evaluation [Time frame: The day after the P(S)G]
- Children Memory Scale [Time frame: The day after the P(S)G]
- Attention [Time frame: The day after the P(S)G]
- NEPSY-II score [Time frame: The day after the P(S)G]
- Trail Making test score [Time frame: The day after the P(S)G]
- KiTAP subtests score [Time frame: The day after the P(S)G]
Secondary outcome measures (12)
- Sleep disturbance [Time frame: The day after baseline P(S)G]
- 3D facial surface analysis [Time frame: The day after baseline P(S)G]
- 3D facial surface analysis [Time frame: The day after baseline P(S)G]
- 3D facial surface analysis [Time frame: The day after baseline P(S)G]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Correlations with clinical signs of SDB [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Correlations with clinical signs of SDB [Time frame: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Hôpital Necker-Enfants Malades — Paris
Identifiers
NCT: NCT04971850 · APHP210042 · 2020-A03083-36