Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-26 @ 10:37 PM
Study NCT ID:
NCT06265792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-10', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'day 1 and day 20', 'description': 'This scale measures daytime sleepiness. By scoring the level of sleepiness in different situations, it can help evaluate whether a patient has OSA or other sleep disorders.Scores range from 0-24. Higher scores indicate more severe daytime sleepiness.'}], 'secondaryOutcomes': [{'measure': 'Apnea-Hypopnea Index', 'timeFrame': 'day 1 and day 20', 'description': 'Apnea-Hypopnea Index is a method to evaluate the severity of OSA. It calculates the number of apnea and hypopnea events per hour.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:\n\n• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.', 'detailedDescription': 'Obstructive Sleep Apnea is of increasingly high prevalence.\n\nThe goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:\n\n• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years diagnosed with OSA by polysomnography\n* Patients with moderate to severe OSA (AHI \\> 15 events per hour)\n* Patients who have undergone continuous positive airway pressure (CPAP) treatment for at least 3 months but have not achieved satisfactory therapeutic effects\n* Patients who voluntarily agree to receive stellate ganglion block (SGB) treatment and sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with a history of allergy or contraindications to local anesthetics or corticosteroids\n* Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases\n* Patients with a history of neck surgery or cervical spine disease\n* Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of SGB treatment\n* Pregnant or lactating women\n* Patients who have participated in other clinical trials within the past 3 months'}, 'identificationModule': {'nctId': 'NCT06265792', 'acronym': 'OSA', 'briefTitle': 'Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Randomized Controlled Trial to Explore the Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '2024-KY-0125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy.The experimental group was given Stellate Ganglion Block.', 'interventionNames': ['Behavioral: routine rehabilitation treatment', 'Procedure: Stellate ganglion block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy.', 'interventionNames': ['Behavioral: routine rehabilitation treatment']}], 'interventions': [{'name': 'routine rehabilitation treatment', 'type': 'BEHAVIORAL', 'description': 'All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy', 'armGroupLabels': ['The control group', 'The experimental group']}, {'name': 'Stellate ganglion block', 'type': 'PROCEDURE', 'description': 'The patients were provided with Stellate ganglion block , using 0.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.', 'armGroupLabels': ['The experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Center Rehabilitation Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Zhefeng Wang, Master', 'role': 'CONTACT', 'email': 'zhengzhouzhj@qq.com', 'phone': '19501376864'}, {'name': 'Weiji Zhao, Doctor', 'role': 'CONTACT', 'email': 'zwjww2009@163.com', 'phone': '17839973473'}], 'overallOfficials': [{'name': 'Nieto Luis, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Site Coordinator of United Medical Group located in Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeng Changhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}