Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06421051

Transauricular Vagus Nerve Stimulation to Improve Postoperative Sleep Disorders in Elderly Patients A Randomized, Triple-Blind Controlled Study

Led by Beijing Tiantan Hospital · Updated on 2025-01-27

164

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative sleep disorder is a common complication following general anesthesia, especially in elderly patients aged 65 and older who face a higher risk than younger individuals. These sleep disturbances can negatively affect cognitive function, pain perception, and emotional well-being, impacting long-term recovery. Improving sleep quality after surgery in older adults is a growing public health focus to help enhance surgical results and overall physical health. This research is a prospective, randomized, triple-blind clinical trial studying the use of transauricular vagal nerve stimulation to address sleep problems after surgery in elderly patients. Participants will receive transauricular vagal nerve stimulation, a device-based treatment aimed at improving postoperative sleep. The study specifically includes elderly patients undergoing elective non-brain surgery under general anesthesia. The intervention will be applied during the postoperative period to evaluate its effect on sleep quality compared to usual care. Throughout the study, researchers will monitor the incidence of sleep disorders for five days after surgery. Participants will be assessed for sleep disturbances and related outcomes during this period. The study investigates whether this nerve stimulation technique can reduce postoperative sleep disorders and improve recovery in elderly surgical patients.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing non-craniocerebral surgery under elective general anesthesia
  • Age 65 years old
  • American society of Aneshesiologists Grade I to III
  • Sign informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

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Research Team

R

Ruquan Han, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Transauricular vagus nerve electrical stimulation improves postoperative sleep disorders in elderly patients (VNstep): protocol for a randomized controlled clinical trial.

Tianyuan Wang, Youxuan Wu, Xuan Hou...

https://pubmed.ncbi.nlm.nih.gov/41566492