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CompletedNCT06421051VnstepUpdated Oct 7, 2026

Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.

An interventional study of Transauricular Vagal Nerve Stimulation in Vagus Nerve Stimulation, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vagus Nerve Stimulation
03

In context

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 483 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing non-craniocerebral surgery under elective general anesthesia
  • Age ≥65 years old
  • American society of Aneshesiologists Grade I to III
  • Sign informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    high-frequency vagus nerve electrical stimulation

    Device: Transauricular Vagal Nerve Stimulation

  • Placebo comparator
    low-frequency vagus nerve electrical stimulation

    Device: Transauricular Vagal Nerve Stimulation

Interventions

  • DeviceTransauricular Vagal Nerve Stimulation

    Transauricular vagal nerve stimulation

06

What researchers measure

Primary outcomes

  1. Incidence of sleep disorders within 5 days after surgery.

    Time frame: Day 1 to day 5 after surgery.

Secondary outcomes

  1. 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.

    Time frame: Day 1,3,5 after surgery.

  2. 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.

    Time frame: Day1 and 2 after surgery.

07

Study locations

1 site
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing Municipality 100070, China
08

References and documents

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 ↗
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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06421051
Responsible party
Ruquan Han (professor, Beijing Tiantan Hospital) — Principal investigator
First posted
May 20, 2024
Start date
Jun 20, 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026
Last update
Oct 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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