Heart Rate and Breathing Effects on Attention and Memory
HeartBEAM
1 other identifier
interventional
91
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedStudy Start
First participant enrolled
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2023
CompletedResults Posted
Study results publicly available
January 9, 2026
CompletedJanuary 9, 2026
January 1, 2026
10 months
September 6, 2022
September 16, 2025
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Plasma Amyloid Beta (Aβ) Levels
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) Ă— condition ANOVA to test for a time Ă— condition interaction in plasma Aβ levels, assessing group differences in change over time.
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Change in Plasma Ab42/40 Ratio
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) Ă— 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.
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Secondary Outcomes (3)
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
Other Outcomes (2)
Change in Plasma pTau-181/Tau Ratio
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Change in Urine Ab42
Measured from urine samples at lab visits on Weeks 2, 7, and 12
Study Arms (2)
Brain training and paced breathing to stimulate alertness
EXPERIMENTALBrain training and paced breathing to relax
EXPERIMENTALInterventions
Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.
After completing brain training, they will then immediately do one 15-minute session of paced breathing, followed by a second 15-min session of paced breathing later in the day. During the paced breathing sessions, participants will clip a pulse monitor to their ear lobe and try to inhale and exhale in synchrony with a ball that moves up and down on the screen. They will receive heart rate biofeedback regarding whether they are achieving their relaxation/alertness goal.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
Related Publications (1)
Nashiro K, Yoo HJ, Cho C, Kim AJ, Nasseri P, Min J, Dahl MJ, Mercer N, Choupan J, Choi P, Lee HRJ, Choi D, Alemu K, Herrera AY, Ng NF, Thayer JF, Mather M. Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults. Trials. 2024 Mar 15;25(1):190. doi: 10.1186/s13063-024-07943-y.
PMID: 38491546DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 6, 2022
First Posted
November 2, 2022
Study Start
January 11, 2023
Primary Completion
November 6, 2023
Study Completion
November 13, 2023
Last Updated
January 9, 2026
Results First Posted
January 9, 2026
Record last verified: 2026-01