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Short-term efficacy observation of percutaneous auricular vagus nerve stimulation (taVNS) in the treatment of depression with insomnia

Short-term efficacy observation of percutaneous auricular vagus nerve stimulation (taVNS) in the treatment of depression with insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000711
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Moderate depression accompanied by insomnia

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age: 18 to 75 years old, gender not limited. 2. It meets the diagnostic criteria for "depressive disorders" as stipulated in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). 3. The total score of the 17-item Hamilton Depression Scale (HAMD-17) is between 17 and 23 points (moderate depression). 4. Meet the diagnostic criteria for "insomnia disorder" in DSM-5, with a disease course of =3 months. 5. The Pittsburgh Sleep Quality Index (PSQI) score is =8 points. 6. No antidepressant, anti-anxiety or sedative-hypnotic drugs have been taken for at least two weeks before enrollment. Or it has been taken stably for at least 4 weeks. 7. Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Secondary depressive disorders or insomnia caused by organic diseases, drugs or mental disorders. 2. Being in the depressive episode of bipolar disorder, or suffering from depressive or insomnia symptoms caused by dysthymia, reactive depression and other diseases. 3. Severe diseases of internal organs such as the heart, liver and kidneys or nervous system diseases (such as epilepsy). 4. Those with electronic devices implanted in their bodies (such as pacemakers and cochlear implants). 5. The therapeutic target (ear) has skin damage, infection or severe skin diseases. 6. Pregnant or lactating women. 7. Currently participating in other clinical researchers.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Hamilton Depression Scale;

Secondary

MeasureTime frame
Insomnia Severity Index Scale;Actigraphy;Self-rating Anxiety Scale;Fatigue severity scale;Epworth Sleepiness Scale;Heart rate variability;Sleep Diary;

Countries

China

Contacts

Public Contactwangcong

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

wangcong90s@163.com18357130082

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026