Sleep Disorder (Disorder)NCT07272954
Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
A study testing SGB and taVNS in people with Sleep Disorder (Disorder), run by Affiliated Hospital of Jiaxing University.
Trial summary
This study aims to design a prospective, randomized, controlled, dual-center, non-inferiority trial to compare the effects of ultrasound-guided sympathetic ganglion block (SGB) and transcutaneous auricular vagus nerve stimulation (taVNS) on sleep quality following radical mastectomy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- SGB and taVNS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2029
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-80 years who underwent radical surgery for breast cancer
- ASA I-III
Who cannot join
- 1. Patients with coagulation dysfunction;
- Patients with suspected regional infection leading to severe nerve damage in the affected limb;
- Patients with congenital heart disease, coronary artery disease, myocardial infarction, severe cardiac conduction block, or those with implanted cardiac pacemakers;
- Patients with severe neurological disorders such as cerebral infarction, cerebral hemorrhage, or stroke;
- Patients with pain, lesions, infections, or unresolved external ear trauma in the area near the external ear;
- Patients with severe mental illness or a history of substance abuse related to analgesics or psychiatric medications;
- Patients with allergies to local anesthetics such as lidocaine or ropivacaine, as well as to general anesthetics;
- Patients and their families who refuse surgical anesthesia and those unable to complete the survey questionnaire.
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
This study aims to design a prospective, randomized, controlled, dual-center, non-inferiority trial to compare the effects of ultrasound-guided sympathetic ganglion block (SGB) and transcutaneous auricular vagus nerve stimulation (taVNS) on sleep quality following radical mastectomy for breast cancer. The objective is to explore whether non-invasive neuromodulation for sleep is non-inferior to invasive neuromodulation. Participants will be randomly assigned to receive either SGB or taVNS treatment. Sleep quality will be assessed using an actigraphy device and sleep scales within four days post-surgery, and the incidence of sleep disturbances will be followed up within 30 days post-surgery.
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- SGB, taVNS
- Keywords
- taVNS
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGBProcedure or surgery
Before the induction of anesthesia in the operating room, a skilled anesthesiologist performed a SGB under sterile conditions using real-time ultrasound in a blind grouping manner. The patient was positioned supine with the neck slightly rotated to the left. A linear probe (6-13 MHz) was placed on the neck to clearly visualize the carotid artery, internal jugular vein, vertebral artery, vagus nerve, thyroid gland, esophagus, scalene muscles, and the anterior scalene muscle at the C6 level. Subsequently, a 48mm, 20-gauge needle was inserted in a "plane" direction into the prevertebral fascia of the anterior scalene muscle. After the needle tip penetrated the prevertebral fascia and negative pressure aspiration was confirmed, 3ml of 0.5% ropivacaine was injected, and the diffusion of the local anesthetic was observed under ultrasound guidance.
taVNSDevice
Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients: ① According to the manufacturer's recommendations and previous studies [32], the initial adjustment required electrical stimulation to penetrate the skin barrier. The first intervention was conducted one day prior to the surgery, with an initial electrical stimulation frequency set at 30 Hz and a pulse width of 300 μs. The frequency and pulse width were adjusted based on the individual patient's sensations until the maximum tolerable current stimulation was reached without discomfort, lasting for 30 minutes; ② The second intervention occurred immediately after the patient was connected to the monitoring equipment in the operating room, once their vital signs were confirmed to be within normal ranges. The same stimulation frequency as the first intervention was applied for 30 minutes; ③ The third intervention was administered in the recovery room after the patient's surgery
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block（SGB） | Active comparator | Before the induction of anesthesia in the operating room, a skilled anesthesiologist performed a SGB under sterile conditions using real-time ultrasound in a blind grouping manner. Receives: Procedure: SGB |
| transcutaneous vagus nerve stimulation（taVNS） | Experimental | Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients Receives: Device: taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time on the First Night Post-Surgery
Total Sleep Time Monitored by Actigraphy on the First Night Post-Surgery
Measured: the First Night Post-Surgery
Secondary outcomes (5)
Total sleep time from the second to the fourth night post-surgery
Total sleep time each night from the second to the fourth night post-surgery by Actigraphy
Measured: the second to the fourth night post-surgery
Assessment of sleep quality during the first four nights postoperatively
Assessment of sleep quality using the Richards-Campbell Sleep Questionnaire(RCSQ) sleep questionnaire during the first four nights postoperatively. The total score is 150 points, with the minimum score being 0 points. A higher score indicates better postoperative sleep quality.
Measured: during the first four nights postoperatively
sleep quality and the incidence of sleep disturbances on the 30th postoperative day
On the 30th postoperative day, the Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality and the incidence of sleep disturbances.The score ranges from 0 to 21 points, with higher scores indicating worse postoperative sleep quality.A score greater than 7 indicates the presence of sleep disturbance.
Measured: On the 30th postoperative day
The incidence of all complications and mortality within 72 hours postoperatively
The incidence of all complications and mortality within 72 hours postoperatively
Measured: within 72 hours postoperatively
Quality of Recovery score at 24 hours postoperatively (QoR-15).
Quality of Recovery score at 24 hours postoperatively (QoR-15). The score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery quality.
Measured: at 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272954
- Sponsor's protocol ID
- 2025-LP-777
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT07272954
- Acronym / sponsor ID
- 2025-LP-777
- Conditions
- Sleep Disorder (Disorder)
- Keywords
- taVNS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 9 Dec 2025 (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.
This study aims to design a prospective, randomized, controlled, dual-center, non-inferiority trial to compare the effects of ultrasound-guided sympathetic ganglion block (SGB) and transcutaneous auricular vagus nerve stimulation (taVNS) on sleep quality following radical mastectomy for breast cancer. The objective is to explore whether non-invasive neuromodulation for sleep is non-inferior to invasive neuromodulation. Participants will be randomly assigned to receive either SGB or taVNS treatment. Sleep quality will be assessed using an actigraphy device and sleep scales within four days post-surgery, and the incidence of sleep disturbances will be followed up within 30 days post-surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block（SGB） | Active comparator | Procedure: SGBBefore the induction of anesthesia in the operating room, a skilled anesthesiologist performed a SGB under sterile conditions using real-time ultrasound in a blind grouping manner. |
| transcutaneous vagus nerve stimulation（taVNS） | Experimental | Device: taVNSThree stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-80 years who underwent radical surgery for breast cancer
- ASA I-III
Key exclusion criteria (8 listed)
- 1. Patients with coagulation dysfunction;
- Patients with suspected regional infection leading to severe nerve damage in the affected limb;
- Patients with congenital heart disease, coronary artery disease, myocardial infarction, severe cardiac conduction block, or those with implanted cardiac pacemakers;
- Patients with severe neurological disorders such as cerebral infarction, cerebral hemorrhage, or stroke;
- Patients with pain, lesions, infections, or unresolved external ear trauma in the area near the external ear;
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 |
|---|---|---|
| SGBBefore the induction of anesthesia in the operating room, a skilled anesthesiologist performed a SGB under sterile conditions using real-time ultrasound in a blind grouping manner. The patient was positioned supine with the neck slightly rotated to the left. A linear probe (6-13 MHz) was placed on the neck to clearly visualize the carotid artery, internal jugular vein, vertebral artery, vagus nerve, thyroid gland, esophagus, scalene muscles, and the anterior scalene muscle at the C6 level. Subsequently, a 48mm, 20-gauge needle was inserted in a "plane" direction into the prevertebral fascia of the anterior scalene muscle. After the needle tip penetrated the prevertebral fascia and negative pressure aspiration was confirmed, 3ml of 0.5% ropivacaine was injected, and the diffusion of the local anesthetic was observed under ultrasound guidance. | Procedure or surgery | Stellate Ganglion Block（SGB） |
| taVNSThree stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients: ① According to the manufacturer's recommendations and previous studies [32], the initial adjustment required electrical stimulation to penetrate the skin barrier. The first intervention was conducted one day prior to the surgery, with an initial electrical stimulation frequency set at 30 Hz and a pulse width of 300 μs. The frequency and pulse width were adjusted based on the individual patient's sensations until the maximum tolerable current stimulation was reached without discomfort, lasting for 30 minutes; ② The second intervention occurred immediately after the patient was connected to the monitoring equipment in the operating room, once their vital signs were confirmed to be within normal ranges. The same stimulation frequency as the first intervention was applied for 30 minutes; ③ The third intervention was administered in the recovery room after the patient's surgery | Device | transcutaneous vagus nerve stimulation（taVNS） |
Primary outcome
Total Sleep Time on the First Night Post-Surgery
Time frame: the First Night Post-Surgery
Total Sleep Time Monitored by Actigraphy on the First Night Post-Surgery
5 secondary outcomes
Total sleep time from the second to the fourth night post-surgery
Time frame: the second to the fourth night post-surgery
Assessment of sleep quality during the first four nights postoperatively
Time frame: during the first four nights postoperatively
sleep quality and the incidence of sleep disturbances on the 30th postoperative day
Time frame: On the 30th postoperative day
The incidence of all complications and mortality within 72 hours postoperatively
Time frame: within 72 hours postoperatively
Quality of Recovery score at 24 hours postoperatively (QoR-15).
Time frame: at 24 hours postoperatively
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 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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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 SGB and taVNS in people with Sleep Disorder (Disorder), run by Affiliated Hospital of Jiaxing University.
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 2 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 29 Sep 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 Mingzi An (+8618035193080, anmingzizi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time on the First Night Post-Surgery (time frame: the First Night Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.