Sleep Architecture & Cognition in Focal Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Focal Epilepsy (FE) patients and healthy controls will wear an actigraph at home for one week and a home sleep study device at home for one night. Participants will then undergo two nights of testing (at least one week apart) at California Sleep Solutions (CSS) in Sacramento, CA. During the overnight stays, participants will have EEG leads placed and possibly a headband. They will undergo cognitive testing before they go to sleep and again in the morning. During one night of testing, sounds will be played in the room (acoustic stimulation). The sounds should not wake the participants.
详细描述
This study will investigate the interconnections between sleep physiology and cognitive deficits in FE and will provide essential pilot data for an interventional trial to characterize the comprehensive effects of AS/ES on sleep and cognition in FE. The long-term goal of this project is to leverage the connections between sleep, behavior, and neural network activity to develop and implement tailored cognitive and sleep interventions for individuals with epilepsy.
AIM 1: Characterize sleep architecture patterns in Focal Epilepsy (FE) and determine the relationship to cognitive processing.
AIM 2: Determine the effect of Sleep Stimulation (Acoustic and/or electrical - AS/ES) on sleep architecture patterns and cognitive processing in FE.
Aim 1 Hypothesis: Compared to controls, FE patients will exhibit interictal epileptiform discharges (IEDs) as well as reduced sleep spindle density and slow wave power with reduced slow wave sleep spindle oscillations (SW-SSO) coupling.
Aim 1 Hypothesis: Compared to controls, reduced SW-SSO coupling during sleep in FE patients will be associated with poorer memory and attention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will not be aware of whether they have acoustic stimulation or sham stimulation. They will be asleep while they are monitored.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 40 years of age
- •Focal Epilepsy
- •Capacity to fully cooperate and follow directions
- •no other significant neurological disorders which could affect cognition
排除标准
- •Current use of any medications that can significantly affect cognition
- •No severe sleep apnea
研究组 & 干预措施
Acoustic Stimulation (AS)
Participants in this arm will be exposed to acoustic stimulation while they sleep during a night of monitoring.
干预措施: Acoustic Stimulation (AS) (Other)
SHAM Stimulation
Participants in this arm will not be exposed to any stimulation while they have their sleep monitored for one night.
干预措施: SHAM Stimulation (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: screening
used to measure quality and patterns of sleep in adults
Vigor Affect Visual Analog Scale
时间窗: screening
self-administered assessment of mood; scores are from 0-10; depending on the question, higher score can mean more sleepiness or less sleepiness
Stanford Sleepiness Scale
时间窗: participant completes over one week post EMU stay
Alertness Test; charts how alert a participant feels for up to 18 hours of the day for 7 days; scale is from 1-7 with higher scores meaning more sleepiness; abnormal is 4 and above
Epworth Sleepiness Scale
时间窗: screening
subjective measure of a patient's sleepiness; scores are from 0-24 with higher scores meaning more sleepiness; abnormal is 10 and above
Karolinska Sleepiness Scale / Sleep Diary
时间窗: screening
Self-administered indication of sleepiness; scores are from 1-9 with higher scores meaning more sleepiness; abnormal is 7 and above
次要结局
未报告次要终点