Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05602220
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heartrate and Breathing Effects on Attention and Memory 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-09', 'releaseDate': '2025-09-16'}, {'resetDate': '2025-11-24', 'releaseDate': '2025-11-11'}, {'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-09-16'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in plasma pTau-181/tau ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]', 'timeFrame': 'Measured from blood draws at lab visits on Weeks 2, 7, and 12', 'description': '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).'}, {'measure': 'Change in urine Ab42', 'timeFrame': 'Measured from urine samples at lab visits on Weeks 2, 7, and 12', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Change in plasma amyloid beta levels', 'timeFrame': 'Measured from blood draws at lab visits on Weeks 2, 7, and 12', 'description': '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).'}, {'measure': 'Change in plasma Ab42/40 ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]', 'timeFrame': 'Measured from blood draws at lab visits on Weeks 2, 7, and 12', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in brain perivascular space volume', 'timeFrame': 'Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12', 'description': 'We will test whether there are group differences in change in perivascular space volume'}, {'measure': 'Change in hippocampal volume', 'timeFrame': 'Measured from magnetic resonance imaging completed at lab visits on Weeks 2, 7, and 12', 'description': 'We will test whether there are group differences in change in hippocampal volume'}, {'measure': 'Brain training performance on 12 Lumosity games during the breathing intervention (controlling for brain training performance pre intervention)', 'timeFrame': 'Pre intervention (daily during Week 2) and during intervention (daily during Weeks 3-11)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Alzheimer Disease', 'Age-related Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '38491546', 'type': 'DERIVED', 'citation': 'Nashiro K, Yoo HJ, Cho C, Kim AJ, Nasseri P, Min J, Dahl MJ, Mercer N, Choupan J, Choi P, Lee HRJ, Choi D, Alemu K, Herrera AY, Ng NF, Thayer JF, Mather M. Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults. Trials. 2024 Mar 15;25(1):190. doi: 10.1186/s13063-024-07943-y.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* speak English fluently\n* between the age of 50-70\n* healthy adult who weighs at least 110 pounds\n* non-pregnant and non-menstruating (for at least the past year)\n* normal or corrected-to-normal vision and hearing\n* have a home computer with a physical keyboard and have access to reliable internet\n* have an email account that you check regularly\n* have a phone that receives text messages\n* willing to provide a blood sample and a urine sample at three lab visits\n* willing to devote up to 60 minutes daily to the study for 12 weeks (in addition to lab visits)\n\nExclusion Criteria:\n\n* 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)\n* regularly practicing any relaxation, biofeedback, or breathing technique (e.g., meditation) for more than an hour a week\n* regularly played Lumosity games in the past 6 months\n* participated in heart rate biofeedback studies in the USC Emotion \\& Cognition Lab\n* have any conditions listed below that are not safe for MRI\n\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': 'NCT05602220', 'acronym': 'HeartBEAM', 'briefTitle': 'Heartrate and Breathing Effects on Attention and Memory 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Heartrate and Breathing Effects on Attention and Memory Preliminary Study', 'orgStudyIdInfo': {'id': 'UP-21-00357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain training and paced breathing to stimulate alertness', 'interventionNames': ['Behavioral: Brain training', 'Behavioral: Paced breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Brain training and paced breathing to relax', 'interventionNames': ['Behavioral: Brain training', 'Behavioral: Paced breathing']}], 'interventions': [{'name': 'Brain training', 'type': 'BEHAVIORAL', 'description': 'Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.', 'armGroupLabels': ['Brain training and paced breathing to relax', 'Brain training and paced breathing to stimulate alertness']}, {'name': 'Paced breathing', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Brain training and paced breathing to relax', 'Brain training and paced breathing to stimulate alertness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mara Mather', 'investigatorAffiliation': 'University of Southern California'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-16', 'type': 'RELEASE'}, {'date': '2025-10-09', 'type': 'RESET'}, {'date': '2025-11-11', 'type': 'RELEASE'}, {'date': '2025-11-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mara Mather, Professor, University of Southern California'}}}}