Recruiting

CALM

Sponsor:

University of Southern California

Code:

NCT06410157

Conditions

Age-related Cognitive Decline

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Interventions

Daily practice

Study Details

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.

Conditions

Age-related Cognitive Decline

Alzheimer Disease

Study ID

NCT06410157

Start date

Jan 14, 2025

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

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.

Interventions

Daily practice

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

Primary outcome measure

  • Change in plasma amyloid-beta 42 levels [ Time Frame: Week 1 and Week 10 ]

Central Contacts and Locations

Central contacts

Emotion & Cognition Lab Coordinator

213-740-9543matherlab@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Emotion & Cognition Lab Coordinator

213-740-9543matherlab@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-05-13.