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

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.

Study Overview

• Status: Recruiting
• Conditions: Vagus Nerve Stimulation
• Intervention / Treatment: Device: Transauricular Vagal Nerve Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, MD; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Ruquan Han, MD,PhD; Phone Number: 8610-59976660; Email: ruquan.han@gmail.com
      • Contact: Ruquan Han, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-frequency vagus nerve electrical stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal nerve stimulation
Placebo Comparator: low-frequency vagus nerve electrical stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of sleep disorders within 5 days after surgery.	Day 1 to day 5 after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day1 and 2 after surgery.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Parasomnias; Sleep Wake Disorders
• Other Study ID Numbers: HX-B-2024016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No