Cardiac-Control Affecting Learning Through Mindfulness (CALM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorUniversity of Southern California
About this trial
Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. The current study is designed to investigate how daily mindfulness practice with heart rate biofeedback during breathing in a pattern that either increases or decreases heart rate oscillation affect attention and memory and blood biomarkers associated with Alzheimer's disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Fluent in English
Black/African-American or White/European-American
Aged between 50-70 years old
Non-pregnant and non-menstruating (for at least the past year)
Disqualifiers
Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)
Have cognitive impairment
Have regularly played Lumosity games in the past 6 months
Have any conditions listed below that are not safe for MRI
Trial design
Design model
Parallel
Treatments tested in this trial
Daily practice
BehavioralParticipants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Increase OscillationExperimental treatment 1 intervention
Group B: Decrease OscillationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in plasma amyloid-beta 42 levels
Plasma Ab42 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 42 levels (to assess group differences in change).
Time frame
Week 1 and Week 10Secondary outcomes
1
Plasma amyloid-beta 40 levels
Plasma Ab40 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 40 levels (to assess group differences in change).
Time frame
Week 1 and Week 102
Plasma Ab42/40 ratio
Investigators will test for a time X condition interaction with plasma Ab42/40 ratio values as the dependent variable (to assess group differences in change).
Time frame
Week 1 and Week 103
Plasma pTau-181/tTau ratio
Investigators will test for a time X condition interaction with the ratio of pTau-181 and total tau values as the dependent variable (to assess group differences in change).
Time frame
Week 1 and Week 104
Change in brain perivascular space volume
Investigators will test for a time X condition interaction in perivascular space volume.
Time frame
Week 1 and Week 10Other outcomes
1
Locus coeruleus (LC) responses to novel faces
Investigators will test for a time x condition interaction in phasic LC responses to novel faces during an fMRI face-name task.
Time frame
Week 1 and Week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
University of California, Irvine
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov