Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT06410157
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac-Control Affecting Learning Through Mindfulness (CALM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Locus coeruleus (LC) responses to novel faces', 'timeFrame': 'Week 1 and Week 10', 'description': 'Investigators will test for a time x condition interaction in phasic LC responses to novel faces during an fMRI face-name task.'}], 'primaryOutcomes': [{'measure': 'Change in plasma amyloid-beta 42 levels', 'timeFrame': 'Week 1 and Week 10', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Plasma amyloid-beta 40 levels', 'timeFrame': 'Week 1 and Week 10', 'description': '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).'}, {'measure': 'Plasma Ab42/40 ratio', 'timeFrame': 'Week 1 and Week 10', 'description': '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).'}, {'measure': 'Plasma pTau-181/tTau ratio', 'timeFrame': 'Week 1 and Week 10', 'description': '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).'}, {'measure': 'Change in brain perivascular space volume', 'timeFrame': 'Week 1 and Week 10', 'description': 'Investigators will test for a time X condition interaction in perivascular space volume.'}, {'measure': 'Brain training performance on Lumosity games during the breathing intervention', 'timeFrame': 'During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Cognitive Decline', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Fluent in English\n* Black/African-American or White/European-American\n* Aged between 50-70 years old\n* Non-pregnant and non-menstruating (for at least the past year)\n* Have normal or corrected-to-normal vision and hearing\n* Have reliable access to wifi\n* Have an email account that you check regularly\n* Have a phone that receives text messages\n* Agree to provide blood and urine samples at two campus visits\n* Agree to devote up to 50 minutes daily to this study for 10 weeks as well as attend two campus visits\n\nExclusion criteria\n\n* Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)\n* Have cognitive impairment\n* Have regularly played Lumosity games in the past 6 months\n* Have any conditions listed below that are not safe for MRI\n\n * \\*Metal in any parts of your body\n * Claustrophobia\n * Have worked as a machinist, metal worker, or in any profession or hobby grinding metal?\n * Have had an injury to the eye involving a metallic object (e.g., metallic slivers, shavings, or foreign body)\n * Cardiac pacemaker\n * Implanted cardiac defibrillator\n * Aneurysm clip or brain clip\n * Carotid artery vascular clamp\n * Neurostimulator\n * Insulin or infusion pump\n * Spinal fusion stimulator\n * Cochlear, otologic, ear tubes or ear implant\n * Prosthesis (eye/orbital, penile, etc.)\n * Implant held in place by a magnet\n * Heart valve prosthesis\n * Artificial limb or joint\n * Other implants in body or head\n * Electrodes (on body, head or brain)\n * Intravascular stents, filters\n * Shunt (spinal or intraventricular)\n * Vascular access port or catheters\n * IUD\n * Transdermal delivery system or other types of foil patches (e.g., Nitro, Nicotine, Birth control, etc.) that cannot be removed for MRI\n * Shrapnel, buckshot, or bullets\n * Tattooed eyeliner or eyebrows\n * Body piercing(s) that cannot be removed for MRI\n * Metal fragments (eye, head, ear, skin)\n * Internal pacing wires\n * Aortic clips\n * Metal or wire mesh implants\n * Wire sutures or surgical staples\n * Harrington rods (spine)\n * Bone/joint pin, screw, nail, wire, plate\n * Wig or toupee that cannot be removed for MRI\n * Hair implants that involve staples or metal\n * Hearing aid(s) that cannot be removed for MRI\n * Dentures or retainers that cannot be removed for MRI'}, 'identificationModule': {'nctId': 'NCT06410157', 'briefTitle': 'Cardiac-Control Affecting Learning Through Mindfulness (CALM)', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Cardiac-Control Affecting Learning Through Mindfulness (CALM)', 'orgStudyIdInfo': {'id': 'UP-21-00357-main'}, 'secondaryIdInfos': [{'id': 'R01AG080652', 'link': 'https://reporter.nih.gov/quickSearch/R01AG080652', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Increase Oscillation', 'description': 'Participants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation.', 'interventionNames': ['Behavioral: Daily practice']}, {'type': 'EXPERIMENTAL', 'label': 'Decrease Oscillation', 'description': "Participants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation.", 'interventionNames': ['Behavioral: Daily practice']}], 'interventions': [{'name': 'Daily practice', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.', 'armGroupLabels': ['Decrease Oscillation', 'Increase Oscillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emotion & Cognition Lab Coordinator', 'role': 'CONTACT', 'email': 'matherlab@usc.edu', 'phone': '213-740-9543'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Emotion & Cognition Lab Coordinator', 'role': 'CONTACT', 'email': 'matherlab@usc.edu', 'phone': '213-740-9543'}]}, 'ipdSharingStatementModule': {'timeFrame': 'IPD will be shared upon publication of results from those IPD with no end date.', 'ipdSharing': 'YES', 'description': 'All individual scores associated with the primary and secondary outcomes will be shared.\n\nFunctional and structural brain images will be shared. Lumosity game play data will be shared.', 'accessCriteria': 'The investigators plan to use Openneuro.org, but if options change, the investigators may select another database. The plan is to have the data shared at a repository where those who are interested can access it. At Openneuro.org, all data are freely available to all users.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Irvine', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mara Mather', 'investigatorAffiliation': 'University of Southern California'}}}}