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

Vagus Nerve Stimulation Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421051
• Other study ID #: HX-B-2024016
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, MD
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Wake Disorders
• Vagus Nerve Stimulation

Intervention

Device:
• Transauricular Vagal Nerve Stimulation
Transauricular vagal nerve stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sleep disorders within 5 days after surgery.		Day 1 to day 5 after surgery.
Secondary	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.
Secondary	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.