Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-21 @ 3:53 PM
Study NCT ID:
NCT06521632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Stimulation Improves Cognition Under Hypoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The stimulator is put in an opaque box'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function measured by eye-tracking at 1 hour after hypoxia', 'timeFrame': '1 hour after hypoxia'}, {'measure': 'cognitive function measured by eye-tracking at 2 hours after hypoxia', 'timeFrame': '2 hours after hypoxia'}], 'secondaryOutcomes': [{'measure': 'mean arterial blood pressure', 'timeFrame': 'starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes'}, {'measure': 'heart rate', 'timeFrame': 'starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes'}, {'measure': 'saturation of pulse oximetry', 'timeFrame': 'starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes'}, {'measure': 'Cerebral oxygen saturation', 'timeFrame': 'starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes'}, {'measure': 'total sleep time on the first day after hypoxia', 'timeFrame': 'the first day after hypoxia, in a total of 24 hours'}, {'measure': 'sleep efficiency(%) on the first day after hypoxia', 'timeFrame': 'the first day after hypoxia, in a total of 24 hours', 'description': 'sleep efficiency=total sleep time/total recording time'}, {'measure': 'number of awake on the first day after hypoxia', 'timeFrame': 'the first day after hypoxia, in a total of 24 hours'}, {'measure': 'time of awake on the first day after hypoxia', 'timeFrame': 'the first day after hypoxia, in a total of 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical acupoint stimulation', 'cognition', 'hypoxia'], 'conditions': ['Cognition']}, 'descriptionModule': {'briefSummary': 'Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, age from 18 to 50 years\n\nExclusion Criteria:\n\n* cardiopulmonary dysfunction;\n* History of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases;\n* A history of fever or respiratory infection within the last two weeks;\n* Drinking alcohol or poor sleep within the last 24 hours'}, 'identificationModule': {'nctId': 'NCT06521632', 'acronym': 'TREACLE', 'briefTitle': 'Acupoint Stimulation Improves Cognition Under Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Cognitive Function Under Exposure to Hypoxia', 'orgStudyIdInfo': {'id': 'XJH-A-20240319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcutaneous electrical acupoint stimulation', 'description': 'Electrodes are placed at acupoints and connected to the stimulators. Electrical stimulation is given for 2 hours', 'interventionNames': ['Other: transcutaneous electrical acupoint stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Electrodes are placed at acupoints but no electrical stimulation is given'}], 'interventions': [{'name': 'transcutaneous electrical acupoint stimulation', 'type': 'OTHER', 'description': 'Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given for 2 hours.', 'armGroupLabels': ['transcutaneous electrical acupoint stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '+8613891975018'}, {'name': 'Yongzhou Jiang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '+8613891975018'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}