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The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on postoperative sleep disorders in patients undergoing Knee or Hip arthroplasty: A prospective randomized clinical study

The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on postoperative sleep disorders in patients undergoing Knee or Hip arthroplasty: A prospective randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125948
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Knee or Hip arthroplasty

Interventions

active taVNS:Stimulation applied to the cavum conchae (auricular branch of the vagus nerve distribution area) with the following parameters: frequency of 25 Hz, pulse width of 500 µs, duty cycle of 60
sham taVNS:Sham stimulation applied to the cavum conchae (auricular branch of the vagus nerve distribution area). Following the same procedure as active taVNS, the intensity is increased until the pat

Sponsors

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Elective unilateral hip or knee arthroplasty under general anesthesia; 2. Aged 18 years old to 80 years old; 3. ASA score grades I to III; 4. BMI is 18 to 35 kg/m ² [BMI= weight (Kg)/height (m) ²] 5. Ethical, patients voluntarily participate in the test and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preoperative history of mental illness; 2. patients with a history of allergy to the drugs used in this study; 3. Patients who have been taking hypnotic drugs for a long time before the operation or have received physical therapy related to insomnia; 4. Patients who refuse or are unable to cooperate in participating in this study or have conditions that prevent nerve block; 5. Implant a cardiac pacemaker in the body; 6. Patients who participated in other studies.

Design outcomes

Primary

MeasureTime frame
Incidence of severe sleep disturbance;

Secondary

MeasureTime frame
Incidence of severe sleep disturbance;Pain NRS scores; postoperative recovery quality ;

Countries

China

Contacts

Public ContactJunde Han

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

hanjunde416@163.com+86 189 3017 0287

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026