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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Sleep Quality in Patients Undergoing General Anesthesia

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Sleep Quality in Patients Undergoing General Anesthesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113340
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative sleeping disorder

Interventions

Test group:Transcutaneous Auricular Vagus Nerve Stimulation (active stimulation)
Control group:Transcutaneous Auricular Vagus Nerve Stimulation (sham stimulation)

Sponsors

The 983rd Hospital of the Joint Logistic Support Force
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective endoscopic sinus surgery under general anesthesia with endotracheal intubation. 2. Patients able to complete the Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), and Patient Health Questionnaire-9 (PHQ-9) assessments one day before surgery. 3. Age >= 18 years, regardless of gender. 4. American Society of Anesthesiologists (ASA) physical status classification of I or II. 5. Provision of signed informed consent, indicating voluntary participation in the trial by the patient themselves.

Exclusion criteria

Exclusion criteria: 1. Patients with a Pittsburgh Sleep Quality Index (PSQI) score greater than 7 one day before surgery. 2. Patients with severe comorbid cardiovascular, cerebrovascular, hepatic, or renal diseases. 3. Patients on long-term use of narcotic analgesics or sedatives. 4. Patients with a history of psychiatric disorders such as anxiety or depression. 5. Patients with pre-existing sleep apnea syndrome. 6. Patients who have participated in other drug or device clinical trials within 3 months prior to the screening period. 7. Patients considered by the investigator to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disturbance;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Countries

China

Contacts

Public ContactRen Guangli

The 983rd Hospital of the Joint Logistic Support Force

rengl254@163.com+86 135 1222 5705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026