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The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Sleep Quality in Elderly Patients Undergoing Lumbar Spine Surgery and Its Association with Melatonin Circadian Rhythm

The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Sleep Quality in Elderly Patients Undergoing Lumbar Spine Surgery and Its Association with Melatonin Circadian Rhythm.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122972
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-24
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Postoperative sleep disorder

Interventions

intervention group:Using standard treatment parameters, the frequency of the Transcutaneous Auricular Vagus Nerve Stimulation device was set to 25 Hz, the pulse width was 250 µs, and the current inten
control group:Using low-frequency treatment parameters, the frequency of the Transcutaneous Auricular Vagus Nerve Stimulation device was set to 1 Hz, the pulse width was 250 µs, and the current inten

Sponsors

Beijing Jishuitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 65 and 75 years old, with ASA classification of I-III; 2. Planned to undergo elective single-segment or double-segment posterior lumbar interbody fusion surgery (TLIF); expected operation time >= 2 hours; postoperative hospital stay >= 4 days; 3. Patients without sleep disorders before the surgery: PSQI = 6; 4. Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Neurosurgery or cardiac surgery or injury to the cervical vagus nerve or history of surgery; 2. Preoperative severe cognitive dysfunction affecting perioperative cognitive function assessment (e.g., MMSE < 24); 3. Terminal diseases with an expected survival period of less than 6 months; 4. Emergency surgery within 6 hours after admission; 5. Endocrine system diseases (such as Cushing's syndrome, uncontrolled hyperthyroidism/hypothyroidism); 6. Continuous use of drugs that affect melatonin, cortisol secretion or HRV for more than 1 month (such as exogenous glucocorticoids, beta-blockers, melatonin supplements, specific psychotropic drugs); 7. Severe liver or kidney dysfunction (e.g., eGFR < 30 mL/min or Child-Pugh C grade); 8. Skin damage/infection in the auricular region; 9. Severe sinus bradycardia, second-degree or higher AVB, pacemaker implantation or severe arrhythmia.

Design outcomes

Primary

MeasureTime frame
The incidence rate (percentage) of sleep disorders on the 4th day after surgery;

Secondary

MeasureTime frame
Melatonin rhythm;Cortisol rhythm;Sleep bracelet sleep monitoring parameters;Resting/Moving State VAS Score;Cognitive and Delirium Assessment;Postoperative nausea and vomiting score;TNF-a;IL-6;

Countries

China

Contacts

Public ContactChen Chen

Beijing Jishuitan Hospital, Capital Medical University

wjcc1221@163.com+86 135 5233 6267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026