Sleep and Circadian ProblemsNCT07836738
Effect of Stellate Ganglion Block on Sleep Quality in Patients With Depression
A study testing Stellate Ganglion Block in people with Sleep and Circadian Problems, run by Li Juan.
Trial summary
# 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep and Circadian Problems
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 ≥ 8.
- Insomnia Severity Index (ISI) score ≥ 7 or Pittsburgh Sleep Quality Index (PSQI) score ≥ 7.
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
# 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.
Read more
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.
- Conditions
- Sleep and Circadian Problems
- Being tested
- Stellate Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
Using an anterior-lateral approach, participants lie supine with head turned contralaterally to expose the neck. The interspace between the anterior sternocleidomastoid border, trachea and common carotid artery is identified. Skin is disinfected 3 times with iodophor (≥15 cm diameter), then covered with a sterile aperture drape.
A 22-G needle is inserted vertically at the target site. After bony contact with the C6 transverse process, the needle is retracted 0.1-0.2 cm. With negative aspiration for blood and cerebrospinal fluid, inject 6 mL 0.25% ropivacaine (epinephrine 1:200 000) at 1 mL/min to limit bleeding and prolong block effect.
Monitor blood pressure, heart rate, oxygen saturation, and adverse events (hoarseness, Horner syndrome, dyspnea) throughout injection.
| Study group | Role | What they receive |
|---|---|---|
| SGB group | Experimental | Stellate Ganglion Block Receives: Procedure: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency, SOL
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Wake After Sleep Onset, WASO
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Total Sleep Time, TST
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Proportions of each non-rapid eye movement sleep stage
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Proportions of REM, NREM and Wake
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Sleep Efficiency, SE
Measured: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Secondary outcomes (4)
Subjective sleep-onset latency
Measured: 30 minutes after awakening on the corresponding next morning
Subjective Total Sleep Time
Measured: 30 minutes after awakening on the corresponding next morning
Subjective Sleep Efficiency
Measured: 30 minutes after awakening on the corresponding next morning
Sleep Satisfaction
Measured: 30 minutes after awakening on the corresponding next morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep and Circadian ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Juan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Li Juan, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836738
- Sponsor's protocol ID
- BoYi Medical Ethics No.1162026
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be available to qualified researchers after article publication. Data access requires a formal research proposal and signed data-use agreement.
Publications
Liu Y, Liu L, Deng Z, Zhou Y, Xiao L, Tang Y. Application of stellate ganglion modulation in mental disorders and the future prospects of physical therapies. Fundam Res. 2025 Oct 23;6(1):548-559. doi: 10.1016/j.fmre.2025.09.024. eCollection 2026 Jan.
PubMed 41647575Plante DT. The Evolving Nexus of Sleep and Depression. Am J Psychiatry. 2021 Oct 1;178(10):896-902. doi: 10.1176/appi.ajp.2021.21080821.
PubMed 34592843
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Sleep Quality in Patients With Depression
- ClinicalTrials.gov ID
- NCT07836738
- Acronym / sponsor ID
- BoYi Medical Ethics No.1162026
- Conditions
- Sleep and Circadian Problems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Li JuanOther government
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
# 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGB group | Experimental | Procedure: Stellate Ganglion BlockStellate Ganglion Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ≥ 8.
- Insomnia Severity Index (ISI) score ≥ 7 or Pittsburgh Sleep Quality Index (PSQI) score ≥ 7.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockUsing an anterior-lateral approach, participants lie supine with head turned contralaterally to expose the neck. The interspace between the anterior sternocleidomastoid border, trachea and common carotid artery is identified. Skin is disinfected 3 times with iodophor (≥15 cm diameter), then covered with a sterile aperture drape. A 22-G needle is inserted vertically at the target site. After bony contact with the C6 transverse process, the needle is retracted 0.1-0.2 cm. With negative aspiration for blood and cerebrospinal fluid, inject 6 mL 0.25% ropivacaine (epinephrine 1:200 000) at 1 mL/min to limit bleeding and prolong block effect. Monitor blood pressure, heart rate, oxygen saturation, and adverse events (hoarseness, Horner syndrome, dyspnea) throughout injection. | Procedure or surgery | SGB group |
Primary outcome
Sleep Onset Latency, SOL
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Wake After Sleep Onset, WASO
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Total Sleep Time, TST
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Proportions of each non-rapid eye movement sleep stage
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Proportions of REM, NREM and Wake
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
Sleep Efficiency, SE
Time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention
4 secondary outcomes
Subjective sleep-onset latency
Time frame: 30 minutes after awakening on the corresponding next morning
Subjective Total Sleep Time
Time frame: 30 minutes after awakening on the corresponding next morning
Subjective Sleep Efficiency
Time frame: 30 minutes after awakening on the corresponding next morning
Sleep Satisfaction
Time frame: 30 minutes after awakening on the corresponding next morning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 41647575Liu Y, Liu L, Deng Z, Zhou Y, Xiao L, Tang Y. Application of stellate ganglion modulation in mental disorders and the future prospects of physical therapies. Fundam Res. 2025 Oct 23;6(1):548-559. doi: 10.1016/j.fmre.2025.09.024. eCollection 2026 Jan.
- Background: PubMed 34592843Plante DT. The Evolving Nexus of Sleep and Depression. Am J Psychiatry. 2021 Oct 1;178(10):896-902. doi: 10.1176/appi.ajp.2021.21080821.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be available to qualified researchers after article publication. Data access requires a formal research proposal and signed data-use agreement.
Related trials for Sleep and Circadian Problems
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Not yet recruiting
Transdiagnostic Sleep Intervention to Improve Mental Health in Adolescents
Sleep Disturbance, Sleep Problems
Not yet recruitingObservational study
Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy
Sleep and Circadian Problems
RecruitingObservational study
Sleep, Mental Fatigue, and Performance in Students
Mental Fatigue, Sleep and Circadian Problems
Not yet recruiting
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
Infant Sleep Problems, Circadian Rhythm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block in people with Sleep and Circadian Problems, run by Li Juan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tong fu, Master (+8613156561090, futong5533227@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency, SOL (time frame: At baseline (Day 0) and from Night 5 to Morning 6 after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836738, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.