Phase 1 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Electroencephalography (EEG) Power at 40 Hertz (Hz)
研究概览
简要总结
The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC).
Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.
详细描述
The investigator will demonstrate the effect of 40 hertz (Hz) rhythmic light (RL) to promote gamma wave entrainment (rhythmic light [RL]) on: brain response (electroencephalography [EEG]); cognitive performance (working memory task); and subjective sleepiness (questionnaires). The study will recruit 20 adult mild cognitive impairment (MCI) patients and 20 healthy, age-matched controls (HC) to participate in this study.
Sessions will initiate with a 10-minute adaptation period to a low-level ambient light providing illuminance of 15 lux at participants' eye level on a vertical plane, followed by a pre-exposure data collection period, including Karolinska Sleepiness Scale (KSS), EEG, and a working memory task. Participants will experience either 40 Hz RL or placebo RL conditions for a duration of 1 hour, followed by the second data collection period. On the second data collection day, participants will experience the other condition, so that all participants experience both lighting conditions. The experimental sessions will start at 14:00 on each experimental day which will be separated by 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 25
- •For the age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25).
- •Participants must score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)
排除标准
- •All participants must not be taking sleeping medication or oral melatonin
- •Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- •residence in a skilled nursing facility or long-term care
- •Major organ failure (e.g., kidney failure)
- •Uncontrolled generalized disorders such as hypertension or diabetes
- •Obstructing cataracts, macular degeneration, and blindness
- •Severe sleep apnea or restless leg syndrome
- •History of epilepsy
研究组 & 干预措施
Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting
- hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
- sessions, 1 week apart
干预措施: Tailored Rhythmic Lighting Intervention (Device)
Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting
- hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.
- sessions, 1 week apart
干预措施: Placebo Rhythmic Lighting Intervention (Device)
结局指标
主要结局
Change in Electroencephalography (EEG) Power at 40 Hertz (Hz)
时间窗: baseline and during the light intervention
Electroencephalography (EEG) recordings - the change in 40 Hz gamma power, computed by calculating the difference between the average gamma power at baseline (T1) and during the light intervention (T2). This difference was obtained by subtracting baseline 40 Hz power from the intervention 40 Hz power to assess acute neural effects
次要结局
- Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS)(Baseline and 1 hour after intervention (intervention is 2 hours))
- Cognition Using a Working Memory Task(1 hour after intervention (intervention is 2 hours))
研究者
Mariana Figueiro
Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai