Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Sleep study.
- Кому может быть актуально
- Состояния в реестре: Sleep-disordered Breathing (SDB). Базовые параметры: 1 год — 20 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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.
Первичные конечные точки
- Anxiety [Срок оценки: The day after the P(S)G]
- Depression [Срок оценки: The day after the P(S)G]
- Quality of life [Срок оценки: The day after the P(S)G]
- Sensoriality [Срок оценки: The day after the P(S)G]
- NEPSY-II memory evaluation [Срок оценки: The day after the P(S)G]
- Children Memory Scale [Срок оценки: The day after the P(S)G]
- Attention [Срок оценки: The day after the P(S)G]
- NEPSY-II score [Срок оценки: The day after the P(S)G]
- Trail Making test score [Срок оценки: The day after the P(S)G]
- KiTAP subtests score [Срок оценки: The day after the P(S)G]
Вторичные конечные точки (12)
- Sleep disturbance [Срок оценки: The day after baseline P(S)G]
- 3D facial surface analysis [Срок оценки: The day after baseline P(S)G]
- 3D facial surface analysis [Срок оценки: The day after baseline P(S)G]
- 3D facial surface analysis [Срок оценки: The day after baseline P(S)G]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Changing detection of respiratory events [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Correlations with clinical signs of SDB [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
- Correlations with clinical signs of SDB [Срок оценки: The day after baseline P(S)G and 1 year after the intervention/procedure/surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- Hôpital Necker-Enfants Malades — Paris
Идентификаторы
NCT: NCT04971850 · APHP210042 · 2020-A03083-36