The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in functional connectivity of the hippocampus and thalamus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Ferrous metal in the body
- •Currently pregnant or breastfeeding
- •Motor problems that preclude finger tapping task
- •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
结局指标
主要结局
Changes in functional connectivity of the hippocampus and thalamus
时间窗: Approximately 1 week between baseline and follow-up scans
Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI
Changes in sleep physiology
时间窗: across 5 nights of sleep with auditory stimulation
Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband
Changes in hippocampal microstructural integrity
时间窗: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI
Changes in hippocampal activation during motor sequence task (MST)
时间窗: Approximately 1 week between baseline and follow-up scans
Changes in hippocampal activation during the MST as measured by functional MRI
次要结局
- Sleep dependent memory consolidation (SDMC)(Approximately 5 days between pre- and post-stimulation MST administrations)
- Greater gains in typing speed over rest breaks during MST training (micro-offline gains)(Approximately 5 days between pre- and post-stimulation MST administrations)
研究者
Dara S. Manoach, PhD
Professor
Massachusetts General Hospital