Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Differences in slow-oscillation spindle coupling
研究概览
简要总结
The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For healthy controls:
- •Male and female subjects
- •18-50 years of age
- •Proficient in English
- •For schizophrenia patients:
- •Male and female schizophrenia outpatients
- •18-50 years of age
- •Proficient in English
- •Able to give informed consent
排除标准
- •Pregnant females
- •Current use of psychotropic medications (healthy controls only)
- •A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
- •Neurological disorder (including seizure disorder)
- •Significant hearing or vision loss
- •Current substance abuse or dependence (nicotine abuse or dependence is not exclusionary)
- •Any unstable chronic medical condition that affects sleep
- •Diagnosed sleep disorder
研究组 & 干预措施
Schizophrenia
Adult outpatients with a diagnosis of schizophrenia.
干预措施: Placebo (Other)
Schizophrenia
Adult outpatients with a diagnosis of schizophrenia.
干预措施: Auditory Stimulation (Other)
Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
干预措施: Placebo (Other)
Healthy Controls
Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.
干预措施: Auditory Stimulation (Other)
结局指标
主要结局
Differences in slow-oscillation spindle coupling
时间窗: Placebo and auditory stimulation naps will be approximately one week apart
Differences in slow oscillation-spindle coupling during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
次要结局
- Differences in slow oscillations(Placebo and auditory stimulation naps will be approximately one week apart)
- Differences in sleep spindles(Placebo and auditory stimulation naps will be approximately one week apart)
- Differences in sleep-dependent consolidation of motor procedural memory(Placebo and auditory stimulation naps will be approximately one week apart)
研究者
Dara S. Manoach, PhD
Professor
Massachusetts General Hospital