Cardiac-Control Affecting Learning Through Mindfulness (CALM)

NCT ID: NCT06410157

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-14

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Age-related Cognitive Decline Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Increase Oscillation

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

Group Type EXPERIMENTAL

Daily practice

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Daily practice

Intervention Type BEHAVIORAL

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

Interventions

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Daily practice

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Mara Mather

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emotion & Cognition Lab Coordinator

Role: CONTACT

213-740-9543

Facility Contacts

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Emotion & Cognition Lab Coordinator

Role: primary

213-740-9543

Other Identifiers

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R01AG080652

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UP-21-00357-main

Identifier Type: -

Identifier Source: org_study_id

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