Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: routine rehabilitation treatment; Procedure: Stellate ganglion block; Procedure: Placebo injection; Drug: Lidocaine Hydrochloride

• Registration Number: NCT06319612
• Lead Sponsor: Copka Sonpashan

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 (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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate ganglion block+routine rehabilitation treatment	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.The experimental group was given Stellate Ganglion Block.
Stellate ganglion block+routine rehabilitation treatment	Stellate ganglion block	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.
placebo+routine rehabilitation treatment	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.
placebo+routine rehabilitation treatment	Placebo injection	All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy.
Stellate ganglion block+routine rehabilitation treatment	Lidocaine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale	day 1 and day 10	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.

Secondary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	day 1 and day 10	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.