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RecruitingNCT06410157Updated May 13, 2026

Cardiac-Control Affecting Learning Through Mindfulness (CALM)

An interventional study of Daily practice in Age-related Cognitive Decline and Alzheimer Disease, sponsored by University of Southern California. Recruiting at 1 site in United States. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by University of Southern California · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Age-related Cognitive Decline
  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 240 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Increase Oscillation

    Participants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation.

    Behavioral: Daily practice

  • Experimental
    Decrease Oscillation

    Participants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation.

    Behavioral: Daily practice

Interventions

  • BehavioralDaily practice

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

06

What researchers measure

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 10

Secondary 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 10

  2. 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 10

  3. 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 10

  4. 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 10

  5. Brain training performance on Lumosity games during the breathing intervention

    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.

    Time frame: During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)

Other 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 10

07

Study locations

1 of 1 sites recruiting
  • University of Southern California
    Los Angeles, California 90089, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06410157
Lead sponsor
University of Southern California
Collaborators
University of California, Irvine, National Institute on Aging (NIA)
Responsible party
Mara Mather (Professor, University of Southern California) — Principal investigator
First posted
May 13, 2024
Start date
Jan 14, 2025
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
May 13, 2026

Study contacts

Emotion & Cognition Lab Coordinator
Contact
matherlab@usc.edu
213-740-9543

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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