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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain training and paced breathing to stimulate alertness | Experimental |
| |
| Brain training and paced breathing to relax | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 from blood draws at lab visits on Weeks 2, 7, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured from blood draws at lab visits on Weeks 2, 7, and 12 |
| Change in Urine Ab42 |
Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38491546 | Derived | 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. |
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Out of the 91 participants enrolled, 10 dropped after enrolling but before Week 1 home assessments, and an additional 19 dropped before condition assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brain Training and Paced Breathing to Stimulate Alertness | Brain training: 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: 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. |
| FG001 | Brain Training and Paced Breathing to Relax | Brain training: 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: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brain Training and Paced Breathing to Stimulate Alertness | Brain training: 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Z-score | Measured from blood draws at lab visits on Weeks 2, 7, and 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brain Training and Paced Breathing to Stimulate Alertness | Brain training: 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: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bruising following a blood draw | Blood and lymphatic system disorders | Systematic Assessment | Four participants reported experiencing more bruising than usual following their blood draw. However, during follow-up, all participants indicated they were feeling fine and that the bruising was resolving. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | University of Southern California | 213-740-9543 | nashiro@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2023 | Dec 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2025 | Sep 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
| 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 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 at pre-intervention during week 2 and at the end of the intervention during week 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). |
| Measured from urine samples at lab visits on Weeks 2, 7, and 12 |
| BG001 | Brain Training and Paced Breathing to Relax | Brain training: 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: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Brain Training and Paced Breathing to Relax | Brain training: 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: 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 | 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. | Posted | Mean | Standard Error | ratio of Aβ42 to Aβ40 | Measured from blood draws at lab visits on Weeks 2, 7, and 12 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of PVS volume | Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | mm^2 | Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Z-scores | Measured at pre-intervention during week 2 and at the end of the intervention during week 12 |
|
|
|
|
| Other Pre-specified | 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). | Not Posted | Measured from blood draws at lab visits on Weeks 2, 7, and 12 | Participants |
| Other Pre-specified | 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). | Not Posted | Measured from urine samples at lab visits on Weeks 2, 7, and 12 | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | Brain Training and Paced Breathing to Relax | Brain training: 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: 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. | 0 | 31 | 0 | 31 | 3 | 31 |
|
| light-headedness during home practice | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One participant reported experiencing nausea and light-headedness during their daily breathing practices. A researcher advised them to take soft shallow breaths instead of deep breathing, which alleviated the symptoms. |
|
| Discomfort during MRI due to body size | General disorders | Systematic Assessment | Participant experienced discomfort due to body size in MRI scanner. The bed got stuck, causing a brief delay. Staff provided support, and the participant was safely removed. Follow-up confirmed no lasting symptoms or injuries. |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Week 12 |
|
| Week 12 |
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| Week 12 |
|