Effect of Stellate Ganglion Block on Sleep Quality in Patients With Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Proportions of REM, NREM and Wake
研究概览
简要总结
# Brief Summary
This clinical research study looks at whether stellate ganglion block (SGB) can improve sleep quality for people with depression. Poor sleep often goes together with depression. Medicines used for these conditions may cause side-effects or dependency. Researchers want to learn if SGB, a minimally-invasive nerve treatment, can help sleep and mood without those medicine-related downsides.
This study uses a self-controlled design. Every person who joins will receive the study treatment. No separate comparison group is enrolled. Researchers will collect sleep data from each participant before treatment and again after treatment, then compare these two sets of information.
About 42 participants will take part in this study.
Key requirements to join the study:
- Aged 18 to 65 years old
- Have depression-related symptoms and sleep trouble
- Able to understand and sign an informed consent form
- No medical conditions that make SGB unsafe
- Have not taken sleep-affecting medicines or received other sleep-focused treatments in the past one month
- Can follow study schedules and complete all study assessments
People cannot join if they:
- Are younger than 18 years or older than 65 years
- Are pregnant or breastfeeding
- Have known allergies to study-used medicines
- Have unstable serious organ diseases, uncontrolled substance or alcohol dependence
- Cannot keep fixed daily routines or finish all study visits
Study procedures for each participant:
- On study day zero (D0): Study staff will explain the study fully. Participants will sign informed consent. Staff will run physical checks and blood tests. Participants will fill out several simple questionnaires about mood and sleep. Sleep will be measured overnight with a multi-channel sleep recording device called polysomnography (PSG). Participants also keep a short sleep diary.
- From study day one (D1) to day five (D5): Participants get one SGB treatment each day, for a total of five treatments. During SGB, a doctor uses ultrasound guidance to inject small-dose local anesthetic near nerves in the neck. Participants keep completing their sleep diary every day. Study staff watch for any unwanted reactions during each treatment.
- On the night of D5 through early morning of D6: PSG sleep recording will be repeated after the final SGB treatment.
- On study day six (D6): Participants finish the final set of mood-and-sleep questionnaires. Study staff collect all safety information.
Researchers will compare sleep measurements taken before treatment versus after five-day SGB treatment. Collected data includes objective sleep readings from PSG and self-reported sleep information from sleep diaries. Questionnaires will show changes in depression and insomnia symptoms.
Possible benefits: SGB may make participants' sleep better and may ease depression-related symptoms. No benefit is guaranteed for every participant.
Possible risks: SGB is generally safe. Rare unwanted reactions may include temporary hoarseness, local neck-site infection, or drug allergic responses. Study doctors will watch participants closely. If serious problems happen, immediate medical help will be provided.
All participants' private personal information will be protected. Participants can choose to stop taking part in this research at any time without penalty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements.
- •Hamilton Depression Rating Scale (HAMD) score ≥
- •Insomnia Severity Index (ISI) score ≥ 7 or Pittsburgh Sleep Quality Index (PSQI) score ≥
- •No contraindications to stellate ganglion block (SGB); no cervical deformity, trauma, or infection; and no severe cervical spine disease, such as cervical fracture or cervical disc herniation with nerve compression.
- •No use of sedative-hypnotics, anxiolytics, antidepressants, or other medications that may affect sleep within the past month, and no acupuncture, massage, nerve block, or other sleep-related interventions during the same period.
- •Stable vital signs; normal liver and renal function, complete blood count, and coagulation function; and no severe organic diseases of the heart, brain, lungs, liver, or kidneys.
- •Able to strictly follow the required sleep-wake schedule and cooperate with polysomnography (PSG) monitoring and completion of sleep diaries, with good study compliance.
排除标准
- •1: Age <18 or >65 years; pregnant or lactating women; subjects with psychiatric disorders (schizophrenia, mania, etc.) or cognitive impairment who cannot cooperate with the study, to prevent missing data and experimental bias.
- •2: Presence of contraindications to stellate ganglion block, such as coagulation disorders, local skin infection, severe cervical spine disease, hyperthyroidism, glaucoma, or increased intracranial pressure.
- •3: Allergy to ropivacaine, epinephrine, or other drugs used for the block, or a history of drug allergy.
- •4: Use of sedative-hypnotics, anxiolytics, antidepressants, hormonal medications, or other treatments that may affect sleep within the past month.
- •5: Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, hematologic disease, respiratory disease, or other serious organic diseases, or a recent history of surgery or trauma.
- •6: Alcohol dependence or drug dependence, or daily consumption of coffee, strong tea, or other stimulating beverages with inability to abstain during the study period.
- •7: Inability to maintain a fixed sleep-wake schedule during the study or inability to complete the full monitoring and intervention procedures because of work, daily life, or other reasons.
- •8: Voluntary withdrawal during the study, or inability to complete the study because of adverse reactions, poor compliance, or other reasons.
研究组 & 干预措施
SGB group
Stellate Ganglion Block
干预措施: Stellate Ganglion Block (Procedure)
结局指标
主要结局
Proportions of REM, NREM and Wake
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Sleep Efficiency, SE
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Wake After Sleep Onset, WASO
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Total Sleep Time, TST
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Proportions of each non-rapid eye movement sleep stage
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Sleep Onset Latency, SOL
时间窗: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
次要结局
- Subjective sleep-onset latency(30 minutes after awakening on the corresponding next morning)
- Subjective Total Sleep Time(30 minutes after awakening on the corresponding next morning)
- Subjective Sleep Efficiency(30 minutes after awakening on the corresponding next morning)
- Sleep Satisfaction(30 minutes after awakening on the corresponding next morning)
研究者
Li Juan
Chief Physician
Anhui Provincial Hospital