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Perioperative dual-session transcutaneous auricular vagus nerve stimulation (taVNS) reduces the incidence of clinically significant postoperative sleep disturbance (POSD) after gynecologic laparoscopy compared with sham stimulation.

This protocol describes a randomized, double-blind, sham-controlled trial to test whether perioperative taVNS (two sessions: 30 min before anesthesia induction and 5 min after extubation) reduces the incidence of POSD (AIS score ≥6) on postoperative day 1. The trial plans to enroll 116 patients aged 18-65 undergoing elective gynecologic laparoscopy. The primary endpoint is the incidence of POSD on postoperative day 1, with secondary endpoints including sleep quality trajectory, anxiety/depression, recovery quality, and EEG spectral analyses.

Last updated: Aug 26, 20261 RCTs📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★
Confidencelow

Study Evidence

Study 1. Perioperative transcutaneous auricular vagus nerve stimulation and EEG biomarkers of sleep improvement after gynecologic laparoscopy: protocol for a randomized controlled trial.

observational

Huang XQ, Zhang LX, Zheng LH, Wang Z, Yao WS, Wang QY, Wang J · Frontiers in medicine (2026)

Participants: N/A
Duration: Not specified (perioperative period, with follow-up on postoperative day 1 and likely beyond)
Intervention: Perioperative dual-session transcutaneous auricular vagus nerve stimulation (taVNS) applied to the left cymba conchae (20 Hz, 250 μs) for 30 min before anesthesia induction and 5 min after extubation, compared with sham stimulation.
Outcome: Incidence of clinically significant postoperative sleep disturbance (POSD) on postoperative day 1 (AIS score ≥6); secondary outcomes include sleep quality trajectory (AIS, actigraphy), anxiety/depression (HADS), recovery quality (QoR-15), and EEG spectral analyses.
Effect Size: N/A (protocol paper, no results reported)
Population: Patients aged 18-65 years scheduled for elective gynecologic laparoscopy (planned n=116).

Result:

Mechanism Graph

taVNS activates afferent vagal pathways
Modulates thalamocortical oscillations
Influences cortical oscillatory dynamics during perioperative period
Prevents acute sleep disruption and reduces POSD incidence

Limitations

  • Protocol paper, no results yet; efficacy not established.
  • Single-center design may limit generalizability.
  • Sham stimulation may not be fully inert, potentially reducing contrast between groups.
  • Primary outcome relies on self-reported AIS score, which may be subjective.

Frequently Asked Questions

What is the primary outcome of this trial?

The primary outcome is the incidence of clinically significant postoperative sleep disturbance (POSD) on postoperative day 1, defined as an Athens Insomnia Scale (AIS) score ≥6.

How is taVNS administered in this trial?

taVNS is applied to the left cymba conchae at 20 Hz with 250 μs pulse width, for two 30-minute sessions: one before anesthesia induction and one after extubation.

What is the sample size and study design?

This is a single-center, randomized, double-blind, sham-controlled trial with 116 patients allocated 1:1 to active taVNS or sham stimulation.

What are the secondary outcomes measured?

Secondary outcomes include sleep quality trajectory (AIS, actigraphy), anxiety and depression (HADS), recovery quality (QoR-15), and exploratory EEG spectral analyses.

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References

  1. 1.Huang XQ, Zhang LX, Zheng LH, Wang Z, Yao WS, Wang QY, Wang J. "Perioperative transcutaneous auricular vagus nerve stimulation and EEG biomarkers of sleep improvement after gynecologic laparoscopy: protocol for a randomized controlled trial.." Frontiers in medicine, 2026. PMID: 42630423 DOI: 10.3389/fmed.2026.1880911
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.