Cardiac-Control Affecting Learning Through Mindfulness (CALM)
2 other identifiers
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
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
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
May 13, 2024
CompletedStudy Start
First participant enrolled
January 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
March 13, 2025
March 1, 2025
2.8 years
May 6, 2024
March 10, 2025
Conditions
Outcome Measures
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).
Week 1 and Week 10
Secondary Outcomes (5)
Plasma amyloid-beta 40 levels
Week 1 and Week 10
Plasma Ab42/40 ratio
Week 1 and Week 10
Plasma pTau-181/tTau ratio
Week 1 and Week 10
Change in brain perivascular space volume
Week 1 and Week 10
Brain training performance on Lumosity games during the breathing intervention
During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)
Other Outcomes (1)
Locus coeruleus (LC) responses to novel faces
Week 1 and Week 10
Study Arms (2)
Increase Oscillation
EXPERIMENTALParticipants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation.
Decrease Oscillation
EXPERIMENTALParticipants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation.
Interventions
Participants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.
Eligibility Criteria
You may qualify if:
- 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)
- Have normal or corrected-to-normal vision and hearing
- Have reliable access to wifi
- Have an email account that you check regularly
- Have a phone that receives text messages
- Agree to provide blood and urine samples at two campus visits
- Agree to devote up to 50 minutes daily to this study for 10 weeks as well as attend two campus visits
You may not qualify if:
- 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
- \*Metal in any parts of your body
- 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
- University of Southern Californialead
- University of California, Irvinecollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 6, 2024
First Posted
May 13, 2024
Study Start
January 14, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- IPD will be shared upon publication of results from those IPD with no end date.
- Access Criteria
- The investigators plan to use Openneuro.org, but if options change, the investigators may select another database. The plan is to have the data shared at a repository where those who are interested can access it. At Openneuro.org, all data are freely available to all users.
All individual scores associated with the primary and secondary outcomes will be shared. Functional and structural brain images will be shared. Lumosity game play data will be shared.