Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-04 @ 1:49 AM
Study NCT ID:
NCT06421051
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2024-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of sleep disorders within 5 days after surgery.', 'timeFrame': 'Day 1 to day 5 after surgery.'}], 'secondaryOutcomes': [{'measure': 'Sleep quality after surgery.', 'timeFrame': 'Day 1,3,5 after surgery.', 'description': 'The investigators collected patient-related information on postoperative days 1, 3, and 5 by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21, with higher scores indicating poorer sleep quality) and a sleep monitoring bracelet, and analyzed the subsequent data.'}, {'measure': 'Postoperative pain score', 'timeFrame': 'Day1 and 2 after surgery.', 'description': 'The investigators collected information from the patients on the 1st and 2nd postoperative days by Visual Analogue Scale and analyzed the data subsequently. The scale is based on a 10-cm horizontal line drawn on a piece of paper, with 0 cm at one end of the line indicating "no pain at all" and 10 cm at the other end indicating "extreme pain"; the level of pain increases from 0 to 10 cm, with higher scores indicating more intense pain. The higher the score, the more severe the pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vagus Nerve Stimulation']}, 'descriptionModule': {'briefSummary': 'Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing non-craniocerebral surgery under elective general anesthesia\n* Age ≥65 years old\n* American society of Aneshesiologists Grade I to III\n* Sign informed consent\n\nExclusion Criteria:\n\n* Patients who are expected to retain tracheal intubation after surgery\n* Disturbance of consciousness, mental disorder, inability to cooperate\n* Expected survival \\< 3 months\n* The estimated operation time is \\< 2 hours\n* The expected postoperative hospital stay is \\< 5 days'}, 'identificationModule': {'nctId': 'NCT06421051', 'acronym': 'Vnstep', 'briefTitle': 'Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'HX-B-2024016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high-frequency vagus nerve electrical stimulation', 'interventionNames': ['Device: Transauricular Vagal Nerve Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'low-frequency vagus nerve electrical stimulation', 'interventionNames': ['Device: Transauricular Vagal Nerve Stimulation']}], 'interventions': [{'name': 'Transauricular Vagal Nerve Stimulation', 'type': 'DEVICE', 'description': 'Transauricular vagal nerve stimulation', 'armGroupLabels': ['high-frequency vagus nerve electrical stimulation', 'low-frequency vagus nerve electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruquan Han, MD,PhD', 'role': 'CONTACT', 'email': 'ruquan.han@gmail.com', 'phone': '8610-59976660'}, {'name': 'Ruquan Han, MD,PhD', 'role': 'CONTACT'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ruquan Han, MD', 'role': 'CONTACT', 'email': 'ruquan.han@ccmu.edu.cn', 'phone': '8610-59976660'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ruquan Han', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}