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Stellate Ganglion Block in Obstructive Sleep Apnea

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06249490
Enrollment
80
Registered
2024-02-08
Start date
2024-02-29
Completion date
2024-05-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

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.

Interventions

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

DEVICEStellate 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.

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.

Sponsors

Zeng Changhao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epworth Sleepiness Scaleday 1 and day 20This 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.

Secondary

MeasureTime frameDescription
Apnea-Hypopnea Indexday 1 and day 20Apnea-Hypopnea Index is a method to evaluate the severity of Obstructive Sleep Apnea. It calculates the number of apnea and hypopnea events per hour.

Countries

Taiwan

Contacts

Primary ContactQuanman Li, Master
liquanman@126.com13958456864
Backup ContactQiao Lian, Master
lianqiao@126.com15333828358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026