Stellate Ganglion Block in Obstructive Sleep Apnea

A Randomized Controlled Trial to Explore the Effect 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: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: routine rehabilitation treatment; Device: Stellate ganglion block; Drug: Lidocaine Hydrochloride Injection

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: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quanman Li, Master; Phone Number: 13958456864; Email: liquanman@126.com
• Study Contact Backup: Name: Qiao Lian, Master; Phone Number: 15333828358; Email: lianqiao@126.com

Study Locations

• Taiwan
  • Xinzhu, Taiwan
    • Recruiting
    • Xinzhu Rehabilitation Hospital
    • Contact: Haim Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography
• Patients with moderate to severe Obstructive Sleep Apnea
• Patients who have undergone continuous positive airway pressure treatment for at least 3 months but have not achieved satisfactory therapeutic effects
• Patients who voluntarily agree to receive stellate ganglion block 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 Stellate Ganglion Block 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

Number of Arms

2

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.	Behavioral: routine rehabilitation treatment; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy; Device: Stellate ganglion block; 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.; Drug: Lidocaine Hydrochloride Injection; 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.; Other Names: Lidocaine Hydrochloride
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.	Behavioral: routine rehabilitation treatment; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale	This scale measures daytime sleepiness. By scoring the level of sleepiness in different situations, it can help evaluate whether a patient has Obstructive Sleep Apnea or other sleep disorders.Scores range from 0-24. Higher scores indicate more severe daytime sleepiness.	day 1 and day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index	Apnea-Hypopnea Index is a method to evaluate the severity of Obstructive Sleep Apnea. It calculates the number of apnea and hypopnea events per hour.	day 1 and day 20

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Investigators: Study Director: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SGB-OSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No