Moderate-to-severe postoperative sleep disturbance
Conditions
Interventions
The TaVNS group:Transcutaneous auricular vagus nerve stimulation (taVNS) : pulse width 250µs, frequency 30Hz, duty cycle 50%, duration 30min, and stimulation intensity set to the maximum current toler
The control group:Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS): pulse width 250µs, frequency 30Hz, duty cycle 50%, duration 30min, electrical output was limited to an initial 30s
Sponsors
The Third Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, either sex, with BMI < 30 kg/m²; 2. ASA level I or II; 3. Scheduled to undergo orthognathic surgery under general anesthesia; 4. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pre-existing sleep disturbance (Pittsburgh Sleep Quality Index [PSQI] score > 7), restless legs syndrome, or other relevant conditions; 2. Incompatibility of the auricular concha with the stimulator device, or presence of local skin lesions in the auricular region; 3. Recent or long-term use of cholinergic or anticholinergic medications; 4. Anticipated postoperative admission to the intensive care unit (ICU); 5. Presence of sick sinus syndrome, sinus bradycardia (heart rate < 50 beats/min), second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker, cochlear implant, or other electronic devices; 6. Inability to communicate or cooperate preoperatively due to mental or language impairment; 7. Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate to severe sleep disorders on the first postoperative night; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of moderate to severe sleep disorders on the second postoperative night;Sleep quality on the first postoperative night;Sleep quality on the second postoperative night;postoperative wound pain;postoperative sore throat;postoperative nausea and vomiting; | — |
Countries
China
Contacts
Public ContactZhang Xiao
The Third Affiliated Hospital of Air Force Medical University
Outcome results
None listed