NCT05602220

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

September 6, 2022

Results QC Date

September 16, 2025

Last Update Submit

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

EXPERIMENTAL
Behavioral: Brain trainingBehavioral: Paced breathing

Brain training and paced breathing to relax

EXPERIMENTAL
Behavioral: Brain trainingBehavioral: Paced breathing

Interventions

Brain trainingBEHAVIORAL

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

Brain training and paced breathing to relaxBrain training and paced breathing to stimulate alertness
Paced breathingBEHAVIORAL

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.

Brain training and paced breathing to relaxBrain training and paced breathing to stimulate alertness

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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

Locations