Stellate Ganglion Block in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

A Randomized Controlled Trial to Explore the Effect of Stellate Ganglion Block in Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249490
• Other study ID #: SGB-OSA
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: Quanman Li, Master
• Phone: 13958456864
• Email: liquanman[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Xinzhu Rehabilitation Hospital	Xinzhu

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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