- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410157
Heartrate and Breathing Effects on Attention and Memory
May 9, 2024 updated by: Mara Mather, University of Southern California
Heartrate and Breathing Effects on Attention and Memory Main Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emotion & Cognition Lab Coordinator
- Phone Number: 213-740-9543
- Email: matherlab@usc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Increase Oscillation
Participants will breath at a slow "resonance" frequency and receive biofeedback to increase heart rate oscillation.
|
Participants will be asked to undergo daily practice to regulate (either increase or decrease) heart rate oscillation
|
Experimental: Decrease Oscillation
Participants' breathing will not be fixed to particular frequency and they will receive biofeedback to decrease heart rate oscillation.
|
Participants will be asked to undergo daily practice to regulate (either increase or decrease) heart rate oscillation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma amyloid-beta levels
Time Frame: Week 1 and Week 10
|
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
|
Plasma amyloid-beta 42/40 ratio
Time Frame: Week 1 and Week 10
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma pTau-181
Time Frame: Week 1 and Week 10
|
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
|
Plasma pTau-217
Time Frame: Week 1 and Week 10
|
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
|
Change in brain perivascular space volume
Time Frame: Week 1 and Week 10
|
Investigators will test whether there are group differences in change in perivascular space volume
|
Week 1 and Week 10
|
Brain training performance on Lumosity games during the breathing intervention
Time Frame: During intervention (daily during Weeks 2-10)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-21-00357-main
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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