Clinical trial NCT06410157: Cardiac-Control Affecting Learning Through Mindfulness (CALM)
Official title: Cardiac-Control Affecting Learning Through Mindfulness (CALM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Cognitive Decline
Alzheimer Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: National Institute on Aging (NIA)
First posted: 2024-05-13
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in plasma amyloid-beta 42 levels
timeFrame: Week 1 and Week 10
Secondary outcomes:
measure: Plasma amyloid-beta 40 levels
timeFrame: Week 1 and Week 10
measure: Plasma Ab42/40 ratio
timeFrame: Week 1 and Week 10
measure: Plasma pTau-181/tTau ratio
timeFrame: Week 1 and Week 10
measure: Change in brain perivascular space volume
timeFrame: Week 1 and Week 10
measure: Brain training performance on Lumosity games during the breathing intervention
timeFrame: During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)
Other outcomes:
measure: Locus coeruleus (LC) responses to novel faces
timeFrame: Week 1 and Week 10
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: