Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-31 @ 8:01 AM
Study NCT ID:
NCT06778356
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-25
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Environment on the Central and Peripheral Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D001146', 'term': 'Arrhythmia, Sinus'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076624', 'term': 'Built Environment'}], 'ancestors': [{'id': 'D004779', 'term': 'Environment Design'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Sinus Arrhythmia (RSA)', 'timeFrame': 'Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).'}, {'measure': 'Blood pressure', 'timeFrame': 'Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).'}, {'measure': 'Remote Associates Test (RAT)', 'timeFrame': 'Participants will complete the RAT task for 19 minutes (44 trials).', 'description': 'In this study, the remote associates test (RAT) will be used as a challenging task to induce sympathetic arousal. Each RAT item consists of three words, participants will be asked to generate a fourth word/solution associated with the words presented by means of a compound word, synonymy, or semantic association. The participant has provided a fourth/solution word or the 30 second time limit. The task will consist of a total of 39 trials, including 5 practice trials.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rumination, nature exposure, respiratory sinus arrhythmia, blood pressure'], 'conditions': ['Rumination']}, 'descriptionModule': {'briefSummary': 'The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.', 'detailedDescription': 'This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 18 years of age or older.\n\nExclusion Criteria:\n\n* Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.'}, 'identificationModule': {'nctId': 'NCT06778356', 'acronym': 'RUMI', 'briefTitle': 'Effect of Environment on the Central and Peripheral Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Effect of Environment on the Central and Peripheral Nervous System', 'orgStudyIdInfo': {'id': 'STUDY007343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Built environment assignment', 'description': 'Participants will complete the study session in a built environment', 'interventionNames': ['Other: Built environment']}, {'type': 'EXPERIMENTAL', 'label': 'Natural environment', 'description': 'Participants will complete the study session in a natural environment.', 'interventionNames': ['Other: Natural environment']}], 'interventions': [{'name': 'Built environment', 'type': 'OTHER', 'description': 'Participants will complete the study session at a University student center.', 'armGroupLabels': ['Built environment assignment']}, {'name': 'Natural environment', 'type': 'OTHER', 'description': 'Participants will complete the study session in a nature trail.', 'armGroupLabels': ['Natural environment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Susan Rodriguez', 'investigatorAffiliation': 'University of South Florida'}}}}