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Cardiac-Control Affecting Learning Through Mindfulness (CALM)

Cardiac-Control Affecting Learning Through Mindfulness (CALM)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06410157
Enrollment
240
Registered
2024-05-13
Start date
2025-01-14
Completion date
2027-11-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cognitive Decline, Alzheimer Disease

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.

Interventions

BEHAVIORALDaily practice

Participants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.

Sponsors

University of Southern California
Lead SponsorOTHER
University of California, Irvine
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in plasma amyloid-beta 42 levelsWeek 1 and Week 10Plasma 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).

Secondary

MeasureTime frameDescription
Plasma amyloid-beta 40 levelsWeek 1 and Week 10Plasma 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).
Plasma Ab42/40 ratioWeek 1 and Week 10Investigators will test for a time X condition interaction with plasma Ab42/40 ratio values as the dependent variable (to assess group differences in change).
Plasma pTau-181/tTau ratioWeek 1 and Week 10Investigators 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).
Change in brain perivascular space volumeWeek 1 and Week 10Investigators will test for a time X condition interaction in perivascular space volume.
Brain training performance on Lumosity games during the breathing interventionDuring intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)Investigators will compute a general learning factor across performance on all games played daily during the intervention period (Weeks 2-10) and separately across performance on all games played daily before the intervention period (Week 1). Investigators will test for group differences in performance during the intervention, controlling for performance before the intervention.

Countries

United States

Contacts

CONTACTEmotion & Cognition Lab Coordinator
matherlab@usc.edu213-740-9543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026