Heart Rate and Breathing Effects on Attention and Memory

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• Alzheimer Disease 3,678

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 91 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Study arms

• Experimental
  Brain training and paced breathing to stimulate alertness

  Behavioral: Brain training · Behavioral: Paced breathing

• Experimental
  Brain training and paced breathing to relax

  Behavioral: Brain training · Behavioral: Paced breathing

Interventions

• BehavioralBrain training

  Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.

• BehavioralPaced breathing

  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.

Primary outcomes

1. 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) × condition ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.

   Time frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12

2. 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) × 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.

   Time frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12

Secondary outcomes

1. Change in Brain Perivascular Space Volume

   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.

   Time frame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12

2. Change in Hippocampal Volume

   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.

   Time frame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12

3. Brain Training Performance on 12 Lumosity Games

   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 within each game across all participants; therefore, some values may appear negative, reflecting scores below the sample mean. A z-score of 0 represents the sample mean, with higher z-scores indicating better cognitive function. Standardized scores across games were combined using Partial Least Squares Correlation (PLSC) analyses.

   Time frame: Measured at pre-intervention during week 2 and at the end of the intervention during week 12

Other outcomes

1. Change in Plasma pTau-181/Tau Ratio

   We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with plasma pTau-181/tau ratio as the dependent variable (to assess group differences in change).

   Time frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12

2. Change in Urine Ab42

   We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with urine Ab42 as the dependent variable (to assess group differences in change).

   Time frame: Measured from urine samples at lab visits on Weeks 2, 7, and 12

Baseline characteristics

Publications

• 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. PubMed 38491546 ↗

Study documents

• Study protocol · May 15, 2023
• Statistical analysis plan · Sep 2, 2025

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