NCT05602220: HeartBEAM

Heart Rate and Breathing Effects on Attention and Memory

Completed NA Results posted Last updated 9 January 2026

What this trial tests

NA trial testing Brain training in Aging in 91 participants. Completed in 13 November 2023.

Timeline

11 January 2023

Primary endpoint
6 November 2023

13 November 2023

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	91
Start date	11 January 2023
Primary completion	6 November 2023
Estimated completion	13 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Brain training
• Paced breathing

Conditions studied

• Aging — all drugs for Aging →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Age-related Cognitive Decline — all drugs for Age-related Cognitive Decline →

Sponsor

University of Southern California

Who can join

Adults 50 to 70, any sex, with Aging or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Plasma Amyloid Beta (Aβ) Levels Primary · 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 diffe

Week 2

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.343	± 0.161
Brain Training and Paced Breathing to Relax	-0.371	± 0.150

Week 7

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.381	± 0.161
Brain Training and Paced Breathing to Relax	-0.332	± 0.151

Week 12

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.410	± 0.161
Brain Training and Paced Breathing to Relax	-0.387	± 0.150

Change in Plasma Ab42/40 Ratio Primary · 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.

Week 2

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	.040	± .001
Brain Training and Paced Breathing to Relax	.038	± .001

Week 7

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	.041	± .001
Brain Training and Paced Breathing to Relax	.039	± .001

Week 12

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	.040	± .001
Brain Training and Paced Breathing to Relax	.037	± .001

Change in Brain Perivascular Space Volume Secondary · Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12

We tested whether there were group differences in changes in perivascular space (PVS) volume. PVS volume was defined as the percentage of PVS volume relative to white matter volume in the centrum semiovale, our main region of interest.

Week 2

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.0077	± 0.0034
Brain Training and Paced Breathing to Relax	0.0079	± 0.0043

Week 7

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.0083	± 0.0042
Brain Training and Paced Breathing to Relax	0.0088	± 0.0052

Week 12

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	0.0092	± 0.0054
Brain Training and Paced Breathing to Relax	0.0080	± 0.0039

Change in Hippocampal Volume Secondary · Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12

We tested whether there were group differences in changes in hippocampal volume. We performed a two-way mixed ANCOVA on hippocampal volume, with condition as the between-subjects factor and time point (Week 2, 7, 12) as the within-subjects factor, controlling for intracranial volume as a covariate.

Week 2

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	7036	± 105.0
Brain Training and Paced Breathing to Relax	7143	± 99.2

Week 7

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	7038	± 105.6
Brain Training and Paced Breathing to Relax	7124	± 99.8

Week 12

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	7018	± 103.1
Brain Training and Paced Breathing to Relax	7102	± 97.4

Brain Training Performance on 12 Lumosity Games Secondary · Measured at pre-intervention during week 2 and at the end of the intervention during week 12

Participants completed 12 brain-training games on the Lumosity platform (https://www.lumosity.com/) targeting six cognitive domains: Attention, Flexibility, Language, Math, Memory, and Reasoning. Performance scores were expressed in arbitrary units, with minimum scores generally in the hundreds. The exact lower limits vary across games, and the upper limits differ substantially between games. Across all games, higher scores indicate better cognitive performance. For analyses, standardized performance scores (z-scores) were derived from the raw Lumosity game scores. Scores were standardized wi

baseline performance (bin1)

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	-2.9144	± 1.3024
Brain Training and Paced Breathing to Relax	-2.9242	± 1.1478

final performance (bin 10)

Group	Value	95% CI
Brain Training and Paced Breathing to Stimulate Alertness	1.5021	± 2.2580
Brain Training and Paced Breathing to Relax	1.4551	± 1.9558

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brain Training and Paced Breathing to Stimulate Alertness

Serious: 0/31 (0%)

Deaths: 0/31

Brain Training and Paced Breathing to Relax

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (3 terms — click to expand)

Reaction	System	Brain Training and Paced B…	Brain Training and Paced B…
bruising following a blood draw	Blood and lymphatic system disorders	—	—
light-headedness during home practice	Respiratory, thoracic and mediastinal disorders	—	—
Discomfort during MRI due to body size	General disorders	—	—

Data from ClinicalTrials.gov NCT05602220 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults.
   Nashiro K, Yoo HJ, Cho C, Kim AJ, et al · · 2024 · cited 8× · PMID 38491546 · DOI 10.1186/s13063-024-07943-y
2. Electroencephalography, pupillometry, and behavioral evidence for locus coeruleus-noradrenaline system related tonic hyperactivity in older adults.
   Kim AJ, Morales S, Senior J, Mather M. · · 2026 · PMID 41343912 · DOI 10.1016/j.neurobiolaging.2025.11.008