A Randomized Controlled Trial to Explore the Effect of Stellate Ganglion Block in Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Epworth Sleepiness Scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
The experimental group
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.
Intervention: routine rehabilitation treatment (Behavioral)
The experimental group
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.
Intervention: Stellate ganglion block (Device)
The experimental group
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.
Intervention: Lidocaine Hydrochloride Injection (Drug)
The control group
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy.
Intervention: routine rehabilitation treatment (Behavioral)
Outcomes
Primary Outcomes
Epworth Sleepiness Scale
Time Frame: day 1 and day 20
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 Outcomes
- Apnea-Hypopnea Index(day 1 and day 20)
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University