Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06654167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effects of Cold Exposure on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003080', 'term': 'Cold Temperature'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D013696', 'term': 'Temperature'}, {'id': 'D013816', 'term': 'Thermodynamics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-14', 'size': 110303, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-15T09:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences in RNA expression levels detected in serum transcriptomics between the two exposures', 'timeFrame': '1 hour after the exposure session', 'description': 'Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure'}, {'measure': 'Change in brain-derived neurotrophic factor (BDNF) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of BDNF in blood.'}, {'measure': 'Change in glial cell line-derived neurotrophic factor (GDNF) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of GDNF in blood.'}, {'measure': 'Change in γ-aminobutyric acid (GABA) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of GABA in blood.'}, {'measure': 'Change in Interleukin-1β (IL-1β) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of IL-1β in blood.'}, {'measure': 'Change in Interferon-β (IFN-β) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of IFN-β in blood.'}, {'measure': 'Change in glutathione (GSH) concentrations', 'timeFrame': '1:00 P.M. on the day of the exposure session, 1 hour after the exposure session', 'description': 'Change in the concentrations of GSH in blood.'}, {'measure': 'Changes of the scores of thermal sensation questionnaires', 'timeFrame': 'before exposure and immediately after the exposure session', 'description': 'Changes of scores of thermal sensation questionnaires which ranged from -5 to 5. Zero score refers to the thermal comfort sensation. Higher scores refer to more uncomfortable sensations of hot. Lower scores refer to more uncomfortable sensations of cold.'}], 'primaryOutcomes': [{'measure': 'Results of Stroop Tests', 'timeFrame': 'before exposure and immediately after the exposure session', 'description': 'Investigators plan to measure the changes of cognitive function using Stroop Test. The time taken to complete the test could reflect cognitive function, and a shorter time means better cognitive function.'}], 'secondaryOutcomes': [{'measure': 'Results of simple reaction time', 'timeFrame': 'before exposure and immediately after the exposure session', 'description': 'Investigators plan to measure the changes of cognitive function using visual memory test'}, {'measure': 'Activated brain regions demonstrating neural activity related to the high temperature exposure', 'timeFrame': '1 hour after exposure session', 'description': 'Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The fractional amplitude of low frequency fluctuation (fALFF) would be extracted to reflect neural activity of brain regions.'}, {'measure': 'Activated brain regions demonstrating neural connectivity related to the high temperature exposure', 'timeFrame': '1 hour after exposure session', 'description': 'Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The degree of centrality (DC) would be extracted to reflect neural connectivity of brain regions.'}, {'measure': 'Activated brain regions demonstrating neural synchronization related to the high temperature exposure', 'timeFrame': '1 hour after exposure session', 'description': 'Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. The regional homogeneity (ReHo) would be extracted to reflect neural synchronization of brain regions.'}, {'measure': 'Changes of skin temperature', 'timeFrame': 'Skin temperature will be examined during the 2-hour exposure session (i.e., 1:00 P.M. to 3:00 P.M. on the day of the exposure session)', 'description': 'The changes of wrist skin temperature will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low temperature', 'Randomized controlled trial', 'Cognitive function'], 'conditions': ['Cognitive Function']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on cognitive function and the underlying mechanisms.', 'detailedDescription': 'The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include cognitive function tests and magnetic resonance imaging. Investigators plan to collect blood and urine samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in Shanghai during the study period;\n* Body mass index \\> 18.5 and ≤ 28;\n* right-handed;\n* receiving or having received higher education;\n* with the ability to read and understand Chinese smoothly.\n\nExclusion Criteria:\n\n* Smoking and alcohol abuse;\n* Current drug and dietary supplements intake;\n* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;\n* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;\n* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;\n* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;\n* Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;\n* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;\n* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);\n* Subjects with color vision disabilities.'}, 'identificationModule': {'nctId': 'NCT06654167', 'briefTitle': 'Acute Effects of Cold Exposure on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism', 'orgStudyIdInfo': {'id': 'IRB#2024-10-1168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low temperature (15℃) group', 'description': 'Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber.', 'interventionNames': ['Other: Low temperature (15℃) group']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate temperature (22℃) group', 'description': 'Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.', 'interventionNames': ['Other: Moderate temperature (22℃) group']}], 'interventions': [{'name': 'Low temperature (15℃) group', 'type': 'OTHER', 'description': 'The exposure group will be exposed to low temperature (15℃) in a chamber for about 2 hours, resting during the whole period.', 'armGroupLabels': ['Low temperature (15℃) group']}, {'name': 'Moderate temperature (22℃) group', 'type': 'OTHER', 'description': 'The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole period.', 'armGroupLabels': ['Moderate temperature (22℃) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Environmental Health, School of Public Health, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Haidong Kan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renjie Chen', 'investigatorAffiliation': 'Fudan University'}}}}