Heartrate and Breathing Effects on Attention and Memory 1

Alzheimer Disease Clinical Trial

— HeartBEAM  

Official title:

Heartrate and Breathing Effects on Attention and Memory Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602220
• Other study ID #: UP-21-00357
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: November 13, 2023

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 13, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Aging
• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Behavioral:
• Brain training
Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.
• Paced breathing
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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma pTau-181/tau 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 pTau-181/tau ratio as the dependent variable (to assess group differences in change).	Measured from blood draws at lab visits on Weeks 2, 7, and 12
Other	Change in urine Ab42	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).	Measured from urine samples at lab visits on Weeks 2, 7, and 12
Primary	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).	Measured from blood draws at lab visits on Weeks 2, 7, and 12
Primary	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).	Measured from blood draws at lab visits on Weeks 2, 7, and 12
Secondary	Change in brain perivascular space volume	We will test whether there are group differences in change in perivascular space volume	Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
Secondary	Change in hippocampal volume	We will test whether there are group differences in change in hippocampal volume	Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12
Secondary	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.	Pre intervention (daily during Week 2) and during intervention (daily during Weeks 3-11)