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

NCT06421051 | Recruiting DMC

• 1 other identifier: HX-B-2024016
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Incidence of sleep disorders within 5 days after surgery.

  Day 1 to day 5 after surgery.

Secondary Outcomes (2)

• Sleep quality after surgery.

  Day 1,3,5 after surgery.

• Postoperative pain score

  Day1 and 2 after surgery.

Study Arms (2)

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

Interventions

Transauricular Vagal Nerve Stimulation DEVICE

Transauricular vagal nerve stimulation

high-frequency vagus nerve electrical stimulation; low-frequency vagus nerve electrical stimulation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s13063-026-09459-z. Online ahead of print.

  PMID: 41566492 DERIVED

Central Study Contacts

Ruquan Han, MD

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)