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NCT Number: NCT06421051

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

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.

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Key information

Conditions

Vagus Nerve Stimulation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, MD,PhD

CONTACT

[email protected]

8610-59976660

Ruquan Han, MD,PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transauricular Vagal Nerve Stimulation

Device

Transauricular vagal nerve stimulation

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.

    Time frame: Day 1,3,5 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.

  2. Postoperative pain score

    Time frame: Day1 and 2 after surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, MD

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.

Acronym: Vnstep

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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