Sleep disorders (PSD)
Conditions
Interventions
Trial Group:Transcutaneous auricular vagus nerve stimulation (taVNS): frequency 20 Hz, pulse width 250 µs, left concha cavity electrode, single stimulation for 30 minutes, administered once 1 hour bef
Control Group:Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS): frequency 1 Hz, pulse width 250 µs, left concha cavity electrode, single stimulation for 30 minutes, administered once
Sponsors
Fujian Maternity and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18–65 years. 2. American Society of Anesthesiologists (ASA) physical status I–II. 3. Body mass index (BMI) 18–30 kg/m^2. 4. Scheduled for elective gynecological laparoscopic surgery with an expected operative time > 1 hour. 5. Preoperative Pittsburgh Sleep Quality Index (PSQI) score <= 7. 6. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Skin breach, infection, or inflammation of the pinna or external auditory canal (including dermatitis/eczema); 2. History of tinnitus, Meniere’s disease, paroxysmal cardiac arrhythmia, or implanted pacemaker/defibrillator; 3. Prior diagnosis of neuropsychiatric disorders (e.g., depression, anxiety disorders, epilepsy, schizophrenia) or sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome); 4. Severe hepatic or renal impairment (Child-Pugh class C or eGFR < 60 mL/min/1.73 m^2); 5. Allergy to conductive gel or medical adhesive; 6. Intraoperative conversion to open surgery or planned postoperative ICU admission; 7. Pregnancy or breastfeeding; 8. Participated in other intervention trials in the past three months, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative sleep disorder (PSD) incidence (defined as Athens Insomnia Scale (AIS) score =6); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of AIS scores;Anxiety level;Perioperative electroencephalogram (EEG) parameters (power spectral density in delta, theta, alpha, sigma, and beta frequency bands, as well as anesthesia awareness index (Ai), electromyography index (EMG), and burst suppression ratio (BSR));Postoperative pain score;Quality of recovery after surgery;Intraoperative hemodynamic parameters (blood pressure, heart rate) and drug consumption (propofol, remifentanil, rocuronium);Surgical duration, anesthesia duration, and extubation time;Postoperative complications (nausea and vomiting, headache and dizziness, discomfort at stimulation site, nightmares, etc.); | — |
Countries
China
Contacts
Public ContactHuang Xunqi
Fujian Maternity and Child Health Hospital
Outcome results
None listed