Heartrate and Breathing Effects on Attention and Memory

Alzheimer Disease Clinical Trial

Official title:

Heartrate and Breathing Effects on Attention and Memory Main Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410157
• Other study ID #: UP-21-00357-main
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: November 2027

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Emotion & Cognition Lab Coordinator
• Phone: 213-740-9543
• Email: matherlab[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 practice of 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• self identify as Black/African-American or White/European-American

• aged 50-70

• normal or corrected-to-normal vision and hearing

• speak English fluently

• have an email account checked regularly

• have a phone that receives text messages

• willing to provide a blood sample and a urine sample at two lab visits

• willing to devote up to 60 minutes daily to the study for 10 weeks (in addition to lab visits)

Exclusion Criteria:

• cardiac pacemaker

• frequent cardiac arrhythmias

• cognitive impairment

• currently practice any meditation, biofeedback or breathing technique for more than an hour per week

• have regularly played Lumosity games in the past six months

• participated in a previous heart rate variability (HRV) biofeedback study

• have any conditions listed below that are not safe for magnetic resonance imaging (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) 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 Electrodes (on body, head or brain) Intravascular stents, filters Shunt (spinal or intraventricular) Vascular access port or catheters Intrauterine device (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 in body Tattooed eyeliner or eyebrows Body piercing(s) with metal 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 in body 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
• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Behavioral:
• Daily practice
Participants will be asked to undergo daily practice to regulate (either increase or decrease) heart rate oscillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma amyloid-beta levels	Investigators will compute an aggregate value based on both plasma Ab40 and Ab42 levels. This score will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab levels (to assess group differences in change).	Week 1 and Week 10
Primary	Plasma amyloid-beta 42/40 ratio	Investigators will test for a time X condition interaction with plasma Ab42/40 ratio values as the dependent variable (to assess group differences in change).	Week 1 and Week 10
Secondary	Plasma pTau-181	Investigators will test for a time X condition interaction with pTau-181 values as the dependent variable (to assess group differences in change).	Week 1 and Week 10
Secondary	Plasma pTau-217	Investigators will test for a time X condition interaction with pTau-217 values as the dependent variable (to assess group differences in change).	Week 1 and Week 10
Secondary	Change in brain perivascular space volume	Investigators will test whether there are group differences in change in perivascular space volume	Week 1 and Week 10
Secondary	Brain training performance on Lumosity games during the breathing intervention	Investigators will compute a general learning factor across performance on all games played daily during the intervention period (Weeks 2-10).	During intervention (daily during Weeks 2-10)