- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265792
Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea (OSA)
A Randomized Controlled Trial to Explore the Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea
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:
• 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive Sleep Apnea is of increasingly high prevalence.
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:
• 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhefeng Wang, Master
- Phone Number: 19501376864
- Email: zhengzhouzhj@qq.com
Study Contact Backup
- Name: Weiji Zhao, Doctor
- Phone Number: 17839973473
- Email: zwjww2009@163.com
Study Locations
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Seoul, Korea, Republic of
- Center Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged over 18 years diagnosed with OSA by polysomnography
- Patients with moderate to severe OSA (AHI > 15 events per hour)
- Patients who have undergone continuous positive airway pressure (CPAP) treatment for at least 3 months but have not achieved satisfactory therapeutic effects
- Patients who voluntarily agree to receive stellate ganglion block (SGB) treatment and sign the informed consent form
Exclusion Criteria:
- Patients with a history of allergy or contraindications to local anesthetics or corticosteroids
- Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases
- Patients with a history of neck surgery or cervical spine disease
- Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of SGB treatment
- Pregnant or lactating women
- Patients who have participated in other clinical trials within the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The experimental group
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.
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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.
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy
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Active Comparator: The control group
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy.
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All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epworth Sleepiness Scale
Time Frame: day 1 and day 20
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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.
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day 1 and day 20
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apnea-Hypopnea Index
Time Frame: day 1 and day 20
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Apnea-Hypopnea Index is a method to evaluate the severity of OSA.
It calculates the number of apnea and hypopnea events per hour.
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day 1 and day 20
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nieto Luis, Doctor, Site Coordinator of United Medical Group located in Miami
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-KY-0125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
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LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
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Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
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University of California, Los AngelesRecruiting
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Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
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State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
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The Hospital for Sick ChildrenCompleted
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Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
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State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
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Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
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ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
Clinical Trials on Stellate ganglion block
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Tanta UniversityMohamad Gamal Elmawy, M.DRecruiting
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VA Office of Research and DevelopmentAnalydata, IncRecruiting
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