Stellate Ganglion Block in Obstructive Sleep Apnea

NCT06249490 | Recruiting DMC

• 1 other identifier: SGB-OSA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Apnea-Hypopnea Index

  day 1 and day 20

Study Arms (2)

The experimental group

EXPERIMENTAL

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; Device: Stellate ganglion block; Drug: Lidocaine Hydrochloride Injection

The control group

ACTIVE COMPARATOR

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

Interventions

routine rehabilitation treatment BEHAVIORAL

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy

The control group; The experimental group

Stellate ganglion block DEVICE

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.

The experimental group

Lidocaine Hydrochloride Injection DRUG

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.

Also known as: Lidocaine Hydrochloride

The experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Xinzhu Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  STUDY DIRECTOR

Central Study Contacts

Quanman Li, Master

CONTACT

13958456864; liquanman@126.com

Qiao Lian, Master

CONTACT

15333828358; lianqiao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: February 29, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)