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临床试验/NCT05602220
NCT05602220已完成不适用

Heart Rate and Breathing Effects on Attention and Memory

University of Southern California1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2023年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Change in Plasma Amyloid Beta (Aβ) Levels

研究概览

简要总结

In the current study, we will examine how daily paced breathing affects plasma amyloid beta levels and the rate of learning in older adults. Healthy adults aged 50-70 who meet all eligibility criteria will be invited to this study. Participants will be randomly assigned to one of the two conditions: 1) Daily memory and attention training followed by a paced breathing protocol designed to increase relaxation or 2) Daily memory and attention training followed by a paced breathing protocol to increase alertness. Participants will be asked to complete pre and post intervention cognitive testing online, engage in 10 weeks of daily brain training (starting Week 2) and 9 weeks of paced breathing (starting Week 3) at home. They will also be asked to come in for lab visits on Weeks 2, 7 and 12 to provide blood and urine samples to assess amyloid beta levels and to complete magnetic resonance imaging scans to assess perivascular space volume.

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
Single (Investigator)

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

入选标准

  • speak English fluently
  • between the age of 50-70
  • healthy adult who weighs at least 110 pounds
  • non-pregnant and non-menstruating (for at least the past year)
  • normal or corrected-to-normal vision and hearing
  • have a home computer with a physical keyboard and have access to reliable internet
  • have an email account that you check regularly
  • have a phone that receives text messages
  • willing to provide a blood sample and a urine sample at three lab visits
  • willing to devote up to 60 minutes daily to the study for 12 weeks (in addition to lab visits)

排除标准

  • have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, heart disease including coronary artery disease, angina, and arrhythmia, cognitive impairment, dyspnea)
  • regularly practicing any relaxation, biofeedback, or breathing technique (e.g., meditation) for more than an hour a week
  • regularly played Lumosity games in the past 6 months
  • participated in heart rate biofeedback studies in the USC Emotion & Cognition Lab
  • have any conditions listed below that are not safe for MRI
  • 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

Brain training and paced breathing to stimulate alertness

Experimental

干预措施: Brain training (Behavioral)

Brain training and paced breathing to stimulate alertness

Experimental

干预措施: Paced breathing (Behavioral)

Brain training and paced breathing to relax

Experimental

干预措施: Brain training (Behavioral)

Brain training and paced breathing to relax

Experimental

干预措施: Paced breathing (Behavioral)

结局指标

主要结局

Change in Plasma Amyloid Beta (Aβ) Levels

时间窗: Measured from blood draws at lab visits on Weeks 2, 7, and 12

We computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). This score was compared across three time points: Week 2 (pre-intervention), Week 7 (mid-intervention), and Week 12 (post-intervention). We conducted a time (Week 2, 7, 12) × condition ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.

Change in Plasma Ab42/40 Ratio

时间窗: Measured from blood draws at lab visits on Weeks 2, 7, and 12

The plasma Aβ42/40 ratio was calculated by dividing the plasma Aβ42 concentration (pg/mL) by the plasma Aβ40 concentration (pg/mL) at each time point. We conducted a time (Week 2, 7, 12) × condition ANOVA to test for an interaction effect, using plasma Aβ42/40 ratio scores as the dependent variable to assess group differences over time. A higher Aβ42/40 ratio indicates a better outcome, reflecting greater brain clearance of Aβ.

次要结局

  • Change in Brain Perivascular Space Volume(Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12)
  • Change in Hippocampal Volume(Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12)
  • Brain Training Performance on 12 Lumosity Games(Measured at pre-intervention during week 2 and at the end of the intervention during week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Mather

Professor

University of Southern California

研究点 (1)

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