Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Epworth Sleepiness Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Stellate ganglion block+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.
干预措施: routine rehabilitation treatment (Behavioral)
Stellate ganglion block+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.
干预措施: Stellate ganglion block (Procedure)
Stellate ganglion block+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.
干预措施: Lidocaine Hydrochloride (Drug)
placebo+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.
干预措施: routine rehabilitation treatment (Behavioral)
placebo+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.
干预措施: Placebo injection (Procedure)
结局指标
主要结局
Epworth Sleepiness Scale
时间窗: 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.
次要结局
- Apnea-Hypopnea Index(day 1 and day 10)
研究者
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital