Clinical trial NCT05602220: Heartrate and Breathing Effects on Attention and Memory 1
Official title: Heartrate and Breathing Effects on Attention and Memory Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Alzheimer Disease
Age-related Cognitive Decline
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2022-11-02
Enrollment: 91
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: In the current study, we will examine how daily paced breathing affects plasma amyloid beta levels and the rate of learning in older adults. Healthy adults aged 50-70 who meet all eligibility criteria will be invited to this study. Participants will be randomly assigned to one of the two conditions: 1) Daily memory and attention training followed by a paced breathing protocol designed to increase relaxation or 2) Daily memory and attention training followed by a paced breathing protocol to increase alertness. Participants will be asked to complete pre and post intervention cognitive testing online, engage in 10 weeks of daily brain training (starting Week 2) and 9 weeks of paced breathing (starting Week 3) at home. They will also be asked to come in for lab visits on Weeks 2, 7 and 12 to provide blood and urine samples to assess amyloid beta levels and to complete magnetic resonance imaging scans to assess perivascular space volume.


Eligibility criteria: Inclusion Criteria:

* speak English fluently
* between the age of 50-70
* healthy adult who weighs at least 110 pounds
* non-pregnant and non-menstruating (for at least the past year)
* normal or corrected-to-normal vision and hearing
* have a home computer with a physical keyboard and have access to reliable internet
* have an email account that you check regularly
* have a phone that receives text messages
* willing to provide a blood sample and a urine sample at three lab visits
* willing to devote up to 60 minutes daily to the study for 12 weeks (in addition to lab visits)

Exclusion Criteria:

* have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, heart disease including coronary artery disease, angina, and arrhythmia, cognitive impairment, dyspnea)
* regularly practicing any relaxation, biofeedback, or breathing technique (e.g., meditation) for more than an hour a week
* regularly played Lumosity games in the past 6 months
* participated in heart rate biofeedback studies in the USC Emotion \& Cognition Lab
* have any conditions listed below that are not safe for MRI

  * 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 levels
timeFrame: Measured from blood draws at lab visits on Weeks 2, 7, and 12
measure: Change in plasma Ab42/40 ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
timeFrame: Measured from blood draws at lab visits on Weeks 2, 7, and 12
Secondary outcomes:
measure: Change in brain perivascular space volume
timeFrame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
measure: Change in hippocampal volume
timeFrame: Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
measure: Brain training performance on 12 Lumosity games during the breathing intervention (controlling for brain training performance pre intervention)
timeFrame: Pre intervention (daily during Week 2) and during intervention (daily during Weeks 3-11)
Other outcomes:
measure: Change in plasma pTau-181/tau ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
timeFrame: Measured from blood draws at lab visits on Weeks 2, 7, and 12
measure: Change in urine Ab42
timeFrame: Measured from urine samples at lab visits on Weeks 2, 7, and 12
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: