Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 7:20 AM
Study NCT ID:
NCT06405893
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-17
First Post:
2024-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Makes People Better at Naming Pictured Objects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Accuracy for Naming Pictures (% correct)', 'timeFrame': 'Under 1 hour', 'description': 'Percent of valid trials on which correct object names were provided will be computed. The measure was designed for use in this study.'}, {'measure': 'Response Time for Naming Pictures (onset time in ms)', 'timeFrame': 'Under 1 hour', 'description': 'Mean response onset time for valid trials on which correct object names were provided will be computed. The measure was designed for use in this study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Mindfulness', 'Speech Production'], 'conditions': ['Healthy Aging']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Participants will engage with an exercise about mindful breathing or an auditory presentation and then name pictured objects as quickly as they can. They will also complete some surveys and other measures and wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.', 'detailedDescription': 'This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Up to 200 participants between ages 18-35 or 60-80 who are native, fluent speakers of English will engage with an exercise about mindful breathing or an auditory presentation. They will then name pictured objects as quickly as they can. Sessions will be audio recorded for later scoring. Participants will also complete demographics forms, a vocabulary test, and a measure of their current anxiety. Those over age 60 will also complete a cognitive function assessment. Participants will be wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-35 or 60-80\n* Fluent English speaker\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Between ages 36-59\n* Older than age 80\n* Not a fluent English speaker'}, 'identificationModule': {'nctId': 'NCT06405893', 'briefTitle': 'What Makes People Better at Naming Pictured Objects', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Colorado Springs'}, 'officialTitle': 'What Makes People Better at Naming Pictured Objects', 'orgStudyIdInfo': {'id': '2019-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Breathing', 'description': '10 minute mindful breathing exercise', 'interventionNames': ['Behavioral: Mindful breathing exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': '10 minute recorded info about mindfulness', 'interventionNames': ['Behavioral: Mindful breathing exercise']}], 'interventions': [{'name': 'Mindful breathing exercise', 'type': 'BEHAVIORAL', 'description': 'Participants do a 10 minute guided mindful breathing exercise or participants do listen to a 10 minute control recording', 'armGroupLabels': ['Control', 'Mindful Breathing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCCS', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual data as of now. If the study is submitted for publication to a journal that requires it, data will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Colorado Springs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lori James', 'investigatorAffiliation': 'University of Colorado, Colorado Springs'}}}}