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NCT Number: NCT06410157

Cardiac-Control Affecting Learning Through Mindfulness (CALM)

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Location status: Recruiting

Location contact

Emotion & Cognition Lab Coordinator

CONTACT

[email protected]

213-740-9543

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily practice

Behavioral

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

Primary outcomes

  1. Change in plasma amyloid-beta 42 levels

    Time frame: Week 1 and Week 10

    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).

Secondary outcomes

  1. Plasma amyloid-beta 40 levels

    Time frame: Week 1 and Week 10

    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).

  2. Plasma Ab42/40 ratio

    Time frame: Week 1 and Week 10

    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).

  3. Plasma pTau-181/tTau ratio

    Time frame: Week 1 and Week 10

    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).

  4. Change in brain perivascular space volume

    Time frame: Week 1 and Week 10

    Investigators will test for a time X condition interaction in perivascular space volume.

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

    Time frame: During 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.

Other outcomes

  1. Locus coeruleus (LC) responses to novel faces

    Time frame: Week 1 and Week 10

    Investigators will test for a time x condition interaction in phasic LC responses to novel faces during an fMRI face-name task.

Study contacts

Contact information is provided by the study sponsor or research team.

Emotion & Cognition Lab Coordinator

CONTACT

[email protected]

213-740-9543

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of California, Irvine

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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