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Clinical Trials/NCT06319612
NCT06319612
Not yet recruiting
Not Applicable

Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea: A Randomized Controlled Trial

Copka Sonpashan0 sites80 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
routine rehabilitation treatment
Conditions
Obstructive Sleep Apnea
Sponsor
Copka Sonpashan
Enrollment
80
Primary Endpoint
Epworth Sleepiness Scale
Status
Not yet recruiting
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copka Sonpashan
Responsible Party
Sponsor Investigator
Principal Investigator

Copka Sonpashan

Research Director

Chao Phya Abhaibhubejhr Hospital

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: routine rehabilitation treatment

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.

Intervention: Stellate ganglion block

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.

Intervention: Lidocaine Hydrochloride

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.

Intervention: routine rehabilitation treatment

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.

Intervention: Placebo injection

Outcomes

Primary Outcomes

Epworth Sleepiness Scale

Time Frame: 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 Outcomes

  • Apnea-Hypopnea Index(day 1 and day 10)

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