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Heartrate and Breathing Effects on Attention and Memory (HeartBEAM)

Primary Purpose

Aging, Alzheimer Disease, Age-related Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain training
Paced breathing
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Brain training and paced breathing to stimulate alertness

Brain training and paced breathing to relax

Arm Description

Outcomes

Primary Outcome Measures

Change in plasma amyloid beta levels
We will compute an aggregate score based on both plasma Ab40 and Ab42 levels. This score will be compared for Week 2 (pre-intervention), Week 7 (during intervention) and Week 12 (post intervention). We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction in plasma Ab levels (to assess group differences in change).
Change in plasma Ab42/40 ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with plasma Ab42/40 ratio scores as the dependent variable (to assess group differences in change).

Secondary Outcome Measures

Change in brain perivascular space volume
We will test whether there are group differences in change in perivascular space volume
Change in hippocampal volume
We will test whether there are group differences in change in hippocampal volume
Brain training performance on 12 Lumosity games during the breathing intervention (controlling for brain training performance pre intervention)
We will compute a general learning factor across performance on all 12 games played daily during the intervention period (Weeks 3-11). We will also assess game performance in the pre-intervention Week 2 to provide a baseline performance measure for each participant and statistically account for it.

Full Information

First Posted
September 6, 2022
Last Updated
January 12, 2023
Sponsor
University of Southern California
Collaborators
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05602220
Brief Title
Heartrate and Breathing Effects on Attention and Memory
Acronym
HeartBEAM
Official Title
Heartrate and Breathing Effects on Attention and Memory
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Alzheimer Disease, Age-related Cognitive Decline

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain training and paced breathing to stimulate alertness
Arm Type
Experimental
Arm Title
Brain training and paced breathing to relax
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brain training
Intervention Description
Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.
Intervention Type
Behavioral
Intervention Name(s)
Paced breathing
Intervention Description
After completing brain training, they will then immediately do one 15-minute session of paced breathing, followed by a second 15-min session of paced breathing later in the day. During the paced breathing sessions, participants will clip a pulse monitor to their ear lobe and try to inhale and exhale in synchrony with a ball that moves up and down on the screen. They will receive heart rate biofeedback regarding whether they are achieving their relaxation/alertness goal.
Primary Outcome Measure Information:
Title
Change in plasma amyloid beta levels
Description
We will compute an aggregate score based on both plasma Ab40 and Ab42 levels. This score will be compared for Week 2 (pre-intervention), Week 7 (during intervention) and Week 12 (post intervention). We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction in plasma Ab levels (to assess group differences in change).
Time Frame
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Title
Change in plasma Ab42/40 ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
Description
We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with plasma Ab42/40 ratio scores as the dependent variable (to assess group differences in change).
Time Frame
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Secondary Outcome Measure Information:
Title
Change in brain perivascular space volume
Description
We will test whether there are group differences in change in perivascular space volume
Time Frame
Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
Title
Change in hippocampal volume
Description
We will test whether there are group differences in change in hippocampal volume
Time Frame
Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
Title
Brain training performance on 12 Lumosity games during the breathing intervention (controlling for brain training performance pre intervention)
Description
We will compute a general learning factor across performance on all 12 games played daily during the intervention period (Weeks 3-11). We will also assess game performance in the pre-intervention Week 2 to provide a baseline performance measure for each participant and statistically account for it.
Time Frame
Pre intervention (daily during Week 2) and during intervention (daily during Weeks 3-11)
Other Pre-specified Outcome Measures:
Title
Change in plasma pTau-181/tau ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
Description
We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with plasma pTau-181/tau ratio as the dependent variable (to assess group differences in change).
Time Frame
Measured from blood draws at lab visits on Weeks 2, 7, and 12
Title
Change in urine Ab42
Description
We will conduct a time (Week 2, 7, 12) X condition ANOVA to test for a time X condition interaction with urine Ab42 as the dependent variable (to assess group differences in change).
Time Frame
Measured from urine samples at lab visits on Weeks 2, 7, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emotion & Cognition Lab Coordinator
Phone
213-761-5015
Email
uscheartbeam@gmail.com
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emotion & Cognition Lab Coordinator
Phone
213-740-9543
Email
matherlab@usc.edu

12. IPD Sharing Statement

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Heartrate and Breathing Effects on Attention and Memory

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