Trial Outcomes & Findings for Heart Rate and Breathing Effects on Attention and Memory (NCT NCT05602220)
NCT ID: NCT05602220
Last Updated: 2026-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Results posted on
2026-01-09
Participant Flow
Out of the 91 participants enrolled, 10 dropped after enrolling but before Week 1 home assessments, and an additional 19 dropped before condition assignment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heart Rate and Breathing Effects on Attention and Memory
Baseline characteristics by cohort
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=31 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=31 Participants
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.
|
Total
n=62 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
59.77 years
STANDARD_DEVIATION 6.17 • n=8 Participants
|
60.52 years
STANDARD_DEVIATION 5.42 • n=7 Participants
|
60.15 years
STANDARD_DEVIATION 5.77 • n=15 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=8 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=8 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=8 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=8 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=8 Participants
|
31 participants
n=7 Participants
|
62 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Measured from blood draws at lab visits on Weeks 2, 7, and 12We 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.
Outcome measures
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=27 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=31 Participants
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.
|
|---|---|---|
|
Change in Plasma Amyloid Beta (Aβ) Levels
Week 2
|
0.343 Z-score
Standard Deviation 0.161
|
-0.371 Z-score
Standard Deviation 0.150
|
|
Change in Plasma Amyloid Beta (Aβ) Levels
Week 7
|
0.381 Z-score
Standard Deviation 0.161
|
-0.332 Z-score
Standard Deviation 0.151
|
|
Change in Plasma Amyloid Beta (Aβ) Levels
Week 12
|
0.410 Z-score
Standard Deviation 0.161
|
-0.387 Z-score
Standard Deviation 0.150
|
PRIMARY outcome
Timeframe: Measured from blood draws at lab visits on Weeks 2, 7, and 12The 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.
Outcome measures
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=27 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=31 Participants
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.
|
|---|---|---|
|
Change in Plasma Ab42/40 Ratio
Week 2
|
.040 ratio of Aβ42 to Aβ40
Standard Error .001
|
.038 ratio of Aβ42 to Aβ40
Standard Error .001
|
|
Change in Plasma Ab42/40 Ratio
Week 7
|
.041 ratio of Aβ42 to Aβ40
Standard Error .001
|
.039 ratio of Aβ42 to Aβ40
Standard Error .001
|
|
Change in Plasma Ab42/40 Ratio
Week 12
|
.040 ratio of Aβ42 to Aβ40
Standard Error .001
|
.037 ratio of Aβ42 to Aβ40
Standard Error .001
|
SECONDARY outcome
Timeframe: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12We 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.
Outcome measures
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=25 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=29 Participants
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.
|
|---|---|---|
|
Change in Brain Perivascular Space Volume
Week 2
|
0.0077 percentage of PVS volume
Standard Deviation 0.0034
|
0.0079 percentage of PVS volume
Standard Deviation 0.0043
|
|
Change in Brain Perivascular Space Volume
Week 7
|
0.0083 percentage of PVS volume
Standard Deviation 0.0042
|
0.0088 percentage of PVS volume
Standard Deviation 0.0052
|
|
Change in Brain Perivascular Space Volume
Week 12
|
0.0092 percentage of PVS volume
Standard Deviation 0.0054
|
0.0080 percentage of PVS volume
Standard Deviation 0.0039
|
SECONDARY outcome
Timeframe: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12We 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.
Outcome measures
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=26 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=29 Participants
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.
|
|---|---|---|
|
Change in Hippocampal Volume
Week 7
|
7038 mm^2
Standard Error 105.6
|
7124 mm^2
Standard Error 99.8
|
|
Change in Hippocampal Volume
Week 12
|
7018 mm^2
Standard Error 103.1
|
7102 mm^2
Standard Error 97.4
|
|
Change in Hippocampal Volume
Week 2
|
7036 mm^2
Standard Error 105.0
|
7143 mm^2
Standard Error 99.2
|
SECONDARY outcome
Timeframe: Measured at pre-intervention during week 2 and at the end of the intervention during week 12Participants 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.
Outcome measures
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=29 Participants
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.
|
Brain Training and Paced Breathing to Relax
n=31 Participants
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.
|
|---|---|---|
|
Brain Training Performance on 12 Lumosity Games
baseline performance (bin1)
|
-2.9144 Z-scores
Standard Deviation 1.3024
|
-2.9242 Z-scores
Standard Deviation 1.1478
|
|
Brain Training Performance on 12 Lumosity Games
final performance (bin 10)
|
1.5021 Z-scores
Standard Deviation 2.2580
|
1.4551 Z-scores
Standard Deviation 1.9558
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured from blood draws at lab visits on Weeks 2, 7, and 12We 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured from urine samples at lab visits on Weeks 2, 7, and 12We 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).
Outcome measures
Outcome data not reported
Adverse Events
Brain Training and Paced Breathing to Stimulate Alertness
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Brain Training and Paced Breathing to Relax
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brain Training and Paced Breathing to Stimulate Alertness
n=31 participants at risk
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.
|
Brain Training and Paced Breathing to Relax
n=31 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
bruising following a blood draw
|
6.5%
2/31 • 12 weeks
|
6.5%
2/31 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
light-headedness during home practice
|
0.00%
0/31 • 12 weeks
|
3.2%
1/31 • 12 weeks
|
|
General disorders
Discomfort during MRI due to body size
|
3.2%
1/31 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
Additional Information
Director of Clinical Trials
University of Southern California
Phone: 213-740-9543
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place