A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean change on the Continuous Performance Task (CPT) over time
研究概览
简要总结
The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •comfortably ambulatory healthy physical condition
- •normal or corrected to normal visual
- •auditory acuity
- •fluency in spoken English
- •Between 60-85 years old
- •No neurological or psychiatric disorders
- •No substance abuse
- •Not taking anti-depressants
- •Not taking anti-anxiety medication
- •No history of seizures
- •No color blindness
- •No glaucoma
- •No macular degeneration
- •No amblyopia (lazy eye)
- •No strabismus (cross eyed)
- •Aneurysm clip(s)
- •No Cardiac pacemaker
- •No Implanted cardioverter defibrillator (ICD)
- •No Electronic implant or device
- •No Magnetically-activated implant or device
- •No Neurostimulation system
- •No Spinal cord stimulator
- •No Internal electrodes or wires
- •No Bone growth/bone fusion stimulator
- •No Cochlear, otologic, or other ear implant
- •No Insulin or other infusion pump
- •No Implanted drug infusion device
- •No type of prosthesis (eye, penile, etc.)
- •No Heart valve prosthesis
- •No Eyelid spring or wire
- •No Artificial or prosthetic limb
- •No Metallic stent, filter, or coil
- •No Shunt (spinal or intraventricular)
- •No Vascular access port and/or catheter
- •No Radiation seeds or implants
- •No Swan-Ganz or thermodilution catheter
- •No Medication patch (Nicotine, Nitroglycerine)
- •No metallic fragment or metallic foreign body in/on the body that can not be removed
- •No Wire mesh implant
- •No Tissue expander (e.g., breast)
- •No Surgical staples, clips, or metallic sutures
- •No Joint replacement (hip, knee, etc.)
- •No Bone/joint pin, screw, nail, wire, plate, etc.
- •No IUD, diaphragm, or pessary
- •No Dentures or partial plates that can not be removed
- •No Tattoo or permanent makeup
- •No Body piercing jewelry
- •No Claustrophobia
排除标准
- 未提供
研究组 & 干预措施
MediTrain
干预措施: MediTrain (Device)
MediTrain
干预措施: wrist worn multi-sensor watches (Device)
MediTrain
干预措施: Sleep monitor (Device)
结局指标
主要结局
Mean change on the Continuous Performance Task (CPT) over time
时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in sleep quality
时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in sleep quality (i.e., total sleep time / time in bed, therefore this measure incorporates latency to sleep onset, total sleep time, wake after sleep onset and early morning waking, with higher numbers associated with better sleep) over time \[Time Frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants\]
Mean change in measures of stress reactivity over time
时间窗: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task
次要结局
- Mean change in Telomere length (quantified in peripheral blood cells) over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
- Mean change on a distracted attention task over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
- Mean change in Frontal Theta Power over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)
- Mean change in resting state networks over time(baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants)