Vagus Nerve StimulationVnstepNCT06421051
Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.
A study testing Transauricular Vagal Nerve Stimulation in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vagus Nerve Stimulation
- What is being tested?
- Transauricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing non-craniocerebral surgery under elective general anesthesia
- Age ≥65 years old
- American society of Aneshesiologists Grade I to III
- Sign informed consent
Who cannot join
- Patients who are expected to retain tracheal intubation after surgery
- Disturbance of consciousness, mental disorder, inability to cooperate
- Expected survival < 3 months
- The estimated operation time is < 2 hours
- The expected postoperative hospital stay is < 5 days
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.
Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.
- Conditions
- Vagus Nerve Stimulation
- Being tested
- Transauricular Vagal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Vagal Nerve StimulationDevice
Transauricular vagal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| high-frequency vagus nerve electrical stimulation | Experimental | Not described Receives: Device: Transauricular Vagal Nerve Stimulation |
| low-frequency vagus nerve electrical stimulation | Placebo comparator | Not described Receives: Device: Transauricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sleep disorders within 5 days after surgery.
Measured: Day 1 to day 5 after surgery.
Secondary outcomes (2)
Sleep quality after surgery.
The investigators collected patient-related information on postoperative days 1, 3, and 5 by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21, with higher scores indicating poorer sleep quality) and a sleep monitoring bracelet, and analyzed the subsequent data.
Measured: Day 1,3,5 after surgery.
Postoperative pain score
The investigators collected information from the patients on the 1st and 2nd postoperative days by Visual Analogue Scale and analyzed the data subsequently. The scale is based on a 10-cm horizontal line drawn on a piece of paper, with 0 cm at one end of the line indicating "no pain at all" and 10 cm at the other end indicating "extreme pain"; the level of pain increases from 0 to 10 cm, with higher scores indicating more intense pain. The higher the score, the more severe the pain.
Measured: Day1 and 2 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 Jun 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421051
- Sponsor's protocol ID
- HX-B-2024016
- Acronym
- Vnstep
- Status last verified
- Oct 2026
- First submitted
- 10 May 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang T, Wu Y, Hou X, Liang F, Jian M, Yu Y, Wang Y, Liu H, Han R. Transauricular vagus nerve electrical stimulation improves postoperative sleep disorders in elderly patients (VNstep): protocol for a randomized controlled clinical trial. Trials. 2026 Jan 21;27(1):134. doi: 10.1186/s13063-026-09459-z.
PubMed 41566492
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06421051
- Acronym / sponsor ID
- Vnstep / HX-B-2024016
- Conditions
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 20 May 2024 (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.
Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-frequency vagus nerve electrical stimulation | Experimental | Device: Transauricular Vagal Nerve Stimulation |
| low-frequency vagus nerve electrical stimulation | Placebo comparator | Device: Transauricular Vagal Nerve Stimulation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients undergoing non-craniocerebral surgery under elective general anesthesia
- Age ≥65 years old
- American society of Aneshesiologists Grade I to III
- Sign informed consent
Key exclusion criteria (5 listed)
- Patients who are expected to retain tracheal intubation after surgery
- Disturbance of consciousness, mental disorder, inability to cooperate
- Expected survival < 3 months
- The estimated operation time is < 2 hours
- The expected postoperative hospital stay is < 5 days
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 |
|---|---|---|
| Transauricular Vagal Nerve StimulationTransauricular vagal nerve stimulation | Device | high-frequency vagus nerve electrical stimulation, low-frequency vagus nerve electrical stimulation |
Primary outcome
Incidence of sleep disorders within 5 days after surgery.
Time frame: Day 1 to day 5 after surgery.
2 secondary outcomes
Sleep quality after surgery.
Time frame: Day 1,3,5 after surgery.
Postoperative pain score
Time frame: Day1 and 2 after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 41566492Wang T, Wu Y, Hou X, Liang F, Jian M, Yu Y, Wang Y, Liu H, Han R. Transauricular vagus nerve electrical stimulation improves postoperative sleep disorders in elderly patients (VNstep): protocol for a randomized controlled clinical trial. Trials. 2026 Jan 21;27(1):134. doi: 10.1186/s13063-026-09459-z.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular Vagal Nerve Stimulation in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sleep disorders within 5 days after surgery. (time frame: Day 1 to day 5 after surgery.). 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 NCT06421051, which also lists 1 linked publication.
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 7 Oct 2026.