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Completed

NCT Number: NCT05602220

Heart Rate and Breathing Effects on Attention and Memory

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.

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Key information

Conditions

Aging Age-related Cognitive Decline Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • IUD
  • 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

Treatment and study plan

Brain Training

Behavioral

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

Paced breathing

Behavioral

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

    Time frame: 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.

  2. Change in Plasma Ab42/40 Ratio

    Time frame: 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.

Secondary outcomes

  1. Change in Brain Perivascular Space Volume

    Time frame: 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.

  2. Change in Hippocampal Volume

    Time frame: 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.

  3. Brain Training Performance on 12 Lumosity Games

    Time frame: 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 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.

Other outcomes

  1. Change in Plasma pTau-181/Tau Ratio

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

    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).

  2. Change in Urine Ab42

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

    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).

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • University of California, Irvine

Registry information

Acronym: HeartBEAM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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