AgingHeartBEAMNCT05602220
Heart Rate and Breathing Effects on Attention and Memory
A study testing Brain training and Paced breathing in people with Aging and Alzheimer Disease, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Alzheimer Disease, Age-related Cognitive Decline
- What is being tested?
- Brain training and Paced breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 41Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
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.
- Conditions
- Aging, Alzheimer Disease, Age-related Cognitive Decline
- Being tested
- Brain training, Paced breathing
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain trainingBehavioural
Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.
Paced breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain training and paced breathing to stimulate alertness | Experimental | Not described Receives: Behavioral: Brain training; Behavioral: Paced breathing |
| Brain training and paced breathing to relax | Experimental | Not described Receives: Behavioral: Brain training; Behavioral: Paced breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) × 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: Measured from blood draws at lab visits on Weeks 2, 7, and 12
Secondary outcomes (3)
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.
Measured: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
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.
Measured: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
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.
Measured: Measured at pre-intervention during week 2 and at the end of the intervention during week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start11 Jan 2023
- Primary completion6 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Mara Mather, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602220
- Sponsor's protocol ID
- UP-21-00357
- Acronym
- HeartBEAM
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2022
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate and Breathing Effects on Attention and Memory
- ClinicalTrials.gov ID
- NCT05602220
- Acronym / sponsor ID
- HeartBEAM / UP-21-00357
- Conditions
- Aging, Alzheimer Disease, Age-related Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain training and paced breathing to stimulate alertness | Experimental | Behavioral: Brain training, Behavioral: Paced breathing |
| Brain training and paced breathing to relax | Experimental | Behavioral: Brain training, Behavioral: Paced breathing |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain trainingParticipants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions. | Behavioural | Brain training and paced breathing to relax, Brain training and paced breathing to stimulate alertness |
| Paced breathingAfter 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. | Behavioural | Brain training and paced breathing to relax, Brain training and paced breathing to stimulate alertness |
Primary outcome
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.
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.
3 secondary outcomes
Change in Brain Perivascular Space Volume
Time frame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
Change in Hippocampal Volume
Time frame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38491546Nashiro 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.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain training and Paced breathing in people with Aging and Alzheimer Disease, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Amyloid Beta (Aβ) Levels (time frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.