Cardiac-Control Affecting Learning Through Mindfulness (CALM)

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Age-related Cognitive Decline
• Interventions: Behavioral: Daily practice

• Registration Number: NCT06410157
• Lead Sponsor: University of Southern California

Brief 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 mindfulness practice with 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-13
• Status Verified: 2025-01
• Study Start: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decrease Oscillation	Daily practice	Participants' breathing will not be fixed to particular frequency and they will receive biofeedback to decrease heart rate oscillation.
Increase Oscillation	Daily practice	Participants will breath at a slow "resonance" frequency and receive biofeedback to increase heart rate oscillation.

Primary Outcome Measures

Name	Time	Method
Change in plasma amyloid-beta 42 levels	Week 1 and Week 10	Plasma Ab42 levels 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 42 levels (to assess group differences in change).

Secondary Outcome Measures

Name	Time	Method
Plasma amyloid-beta 40 levels	Week 1 and Week 10	Plasma Ab40 levels 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 40 levels (to assess group differences in change).
Plasma Ab42/40 ratio	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).
Plasma pTau-181/tTau ratio	Week 1 and Week 10	Investigators will test for a time X condition interaction with the ratio of pTau-181 and total tau values as the dependent variable (to assess group differences in change).
Change in brain perivascular space volume	Week 1 and Week 10	Investigators will test for a time X condition interaction in perivascular space volume.
Brain training performance on Lumosity games during the breathing intervention	During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)	Investigators will compute a general learning factor across performance on all games played daily during the intervention period (Weeks 2-10) and separately across performance on all games played daily before the intervention period (Week 1). Investigators will test for group differences in performance during the intervention, controlling for performance before the intervention.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States