Cardiac-Control Affecting Learning Through Mindfulness (CALM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in plasma amyloid-beta 42 levels
研究概览
简要总结
Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. The current study is designed to investigate how daily mindfulness practice with heart rate biofeedback during breathing in a pattern that either increases or decreases heart rate oscillation affect attention and memory and blood biomarkers associated with Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in English
- •Black/African-American or White/European-American
- •Aged between 50-70 years old
- •Non-pregnant and non-menstruating (for at least the past year)
- •Have normal or corrected-to-normal vision and hearing
- •Have reliable access to wifi
- •Have an email account that you check regularly
- •Have a phone that receives text messages
- •Agree to provide blood and urine samples at two campus visits
- •Agree to devote up to 50 minutes daily to this study for 10 weeks as well as attend two campus visits
排除标准
- •Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)
- •Have cognitive impairment
- •Have regularly played Lumosity games in the past 6 months
- •Have any conditions listed below that are not safe for MRI
- •*Metal in any parts of your body
- •Claustrophobia
- •Have worked as a machinist, metal worker, or in any profession or hobby grinding metal?
- •Have had an injury to the eye involving a metallic object (e.g., metallic slivers, shavings, or foreign body)
- •Cardiac pacemaker
- •Implanted cardiac defibrillator
- •Aneurysm clip or brain clip
- •Carotid artery vascular clamp
- •Neurostimulator
- •Insulin or infusion pump
- •Spinal fusion stimulator
- •Cochlear, otologic, ear tubes or ear implant
- •Prosthesis (eye/orbital, penile, etc.)
- •Implant held in place by a magnet
- •Heart valve prosthesis
- •Artificial limb or joint
- •Other implants in body or head
- •Electrodes (on body, head or brain)
- •Intravascular stents, filters
- •Shunt (spinal or intraventricular)
- •Vascular access port or catheters
- •Transdermal delivery system or other types of foil patches (e.g., Nitro, Nicotine, Birth control, etc.) that cannot be removed for MRI
- •Shrapnel, buckshot, or bullets
- •Tattooed eyeliner or eyebrows
- •Body piercing(s) that cannot be removed for MRI
- •Metal fragments (eye, head, ear, skin)
- •Internal pacing wires
- •Aortic clips
- •Metal or wire mesh implants
- •Wire sutures or surgical staples
- •Harrington rods (spine)
- •Bone/joint pin, screw, nail, wire, plate
- •Wig or toupee that cannot be removed for MRI
- •Hair implants that involve staples or metal
- •Hearing aid(s) that cannot be removed for MRI
- •Dentures or retainers that cannot be removed for MRI
研究组 & 干预措施
Increase Oscillation
Participants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation.
干预措施: Daily practice (Behavioral)
Decrease Oscillation
Participants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation.
干预措施: Daily practice (Behavioral)
结局指标
主要结局
Change in plasma amyloid-beta 42 levels
时间窗: Week 1 and Week 10
Plasma Ab42 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 42 levels (to assess group differences in change).
次要结局
- Change in brain perivascular space volume(Week 1 and Week 10)
- Plasma amyloid-beta 40 levels(Week 1 and Week 10)
- Plasma Ab42/40 ratio(Week 1 and Week 10)
- Plasma pTau-181/tTau ratio(Week 1 and Week 10)
- Brain training performance on Lumosity games during the breathing intervention(During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1))
研究者
Mara Mather
Professor
University of Southern California