NCT05089682终止不适用
Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Participants to Complete Study
研究概览
简要总结
The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DBS in one of the defined nuclei of interest during the period of the study
- •Be willing and able to give written and oral informed consent
- •Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight
- •All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence.
排除标准
- •Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
- •Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate
- •Pregnancy test positive.
结局指标
主要结局
Participants to Complete Study
时间窗: Through study completion, approximately 1 year
Total number of participants to complete all scheduled study activities
次要结局
- Latency to Sleep Onset(Baseline, post-intervention (approximately 1 night))
- Psychomotor Vigilance Test(Baseline, post-intervention (approximately 1 night))
- Total Sleep Time(Baseline, post-intervention (approximately 1 night))
- Karolinska Sleepiness Scale(Baseline, post-intervention (approximately 1 night))
- Latency to Rapid Eye Movement (REM) Sleep(Baseline, post-intervention (approximately 1 night))
- Number of Awakenings Per Night(Baseline, post-intervention (approximately 1 night))
- Number of Sleep Cycles(Baseline, post-intervention (approximately 1 night))
研究者
Gregory Worrell
Principal Investigator
Mayo Clinic
研究点 (2)
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