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Efficacy and safety of Transcutaneous vagus nerve stimulation in patients with insomnia disorder

Efficacy and safety of Transcutaneous vagus nerve stimulation in patients with insomnia disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078566
Enrollment
Unknown
Registered
2023-12-12
Start date
2022-10-11
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

insomnia disorder

Interventions

Ttrue stimulus group:Transcutaneous vagus nerve stimulation
sham stimulus group:sham stimulation

Sponsors

Beijing Huilongguan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) meeting the diagnostic criteria for insomnia disorders in the International Classification of Sleep Disorders, Third Edition (ICSD-3); (2) Age 18-65, no gender limitation; (3) Have more than 6 years of education (4) The patient agrees to participate in the project and signs the informed consent; (5) There were complaints of insomnia and the insomnia severity index (ISI) =8 at the time of enrollment.

Exclusion criteria

Exclusion criteria: (1) Patients with mental retardation; (2) associated with schizophrenia, depression, anxiety disorder, bipolar disorder and other psychiatric disorders not completely relieve patients; (3) alcohol, drug abusers and drug addicts; (4) Patients with organic brain diseases and severe physical diseases; (5) Accompanied by sleep apnea, restless leg syndrome and other sleep disorders (6) pregnant or lactating women; (7) shift workers and/or frequent flyers across time zones (8) Subjects deemed unsuitable for the study by the clinical investigator.

Design outcomes

Primary

MeasureTime frame
Cure rate;Recurrence rates ;polysomnography (PSG);

Secondary

MeasureTime frame
Anxiety and depression symptoms;social function;cognitive function;

Countries

China

Contacts

Public ContactYunlong Tan

Beijing Huilongguan Hospital

yltan21@126.com+86 10 8302 4523

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026