The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
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: Closed loop auditory stimulation during sleep.
- Кому может быть актуально
- Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 45 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
Обзор
In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan.
Вмешательства
- Другое Closed loop auditory stimulation during sleep
Short bursts of pink noise delivered at precise times during overnight sleep at home.
Первичные конечные точки
- Changes in sleep physiology [Срок оценки: across 5 nights of sleep with auditory stimulation]
- Changes in functional connectivity of the hippocampus and thalamus [Срок оценки: Approximately 1 week between baseline and follow-up scans]
- Changes in hippocampal activation during motor sequence task (MST) [Срок оценки: Approximately 1 week between baseline and follow-up scans]
- Changes in hippocampal microstructural integrity [Срок оценки: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans]
Вторичные конечные точки (2)
- Greater gains in typing speed over rest breaks during MST training (micro-offline gains) [Срок оценки: Approximately 5 days between pre- and post-stimulation MST administrations]
- Sleep dependent memory consolidation (SDMC) [Срок оценки: Approximately 5 days between pre- and post-stimulation MST administrations]
Критерии участия
Критерии включения
- 18-45 years old
- Fluent in English
- Able to give informed consent
Additional inclusion for Adults with schizophrenia:
- A DSM-V confirmed diagnosis of schizophrenia
- Unmedicated or maintained on a stable dose of APDs
Критерии исключения
- Ferrous metal in the body
- Currently pregnant or breastfeeding
- Motor problems that preclude finger tapping task
- IQ <85
- Other neurological disorders, including seizure disorder
- Significant hearing or vision loss
- Chronic medical conditions that affect sleep
- Unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
- Diagnosed sleep disorder, except insomnia
- History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
Additional Exclusion Criteria for Healthy adults:
- History of mental illness
- Current use of psychotropic medications or treatment with medications known to affect sleep or cognition
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Massachusetts General Hospital — Charlestown
Идентификаторы
NCT: NCT06386588 · 2024P000610