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

NCT ID: NCT06421051

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vagus Nerve Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high-frequency vagus nerve electrical stimulation

Group Type EXPERIMENTAL

Transauricular Vagal Nerve Stimulation

Intervention Type DEVICE

Transauricular vagal nerve stimulation

low-frequency vagus nerve electrical stimulation

Group Type PLACEBO_COMPARATOR

Transauricular Vagal Nerve Stimulation

Intervention Type DEVICE

Transauricular vagal nerve stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transauricular Vagal Nerve Stimulation

Transauricular vagal nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruquan Han

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ruquan Han, MD

Role: CONTACT

8610-59976660

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ruquan Han, MD,PhD

Role: primary

8610-59976660

Ruquan Han, MD,PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HX-B-2024016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effects of taVNS on Motivation in MDD With Anhedonia
NCT06026904 ENROLLING_BY_INVITATION NA