Insomnia Disorder
Conditions
Interventions
Intervention Group:Percutaneous ear vagus nerve sham stimulation group
Sponsors
Hefei Cancer Hospital,Chinese Academy of Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18–70 years with insomnia disorder, regardless of gender. 2.Meets the diagnostic criteria of ICSD-3 and DSM-5 for insomnia disorder. 3.A Pittsburgh Sleep Quality Index (PSQI) total score > 8, with clinically significant sleep quality impairment. 4.Be capable of understanding and cooperating in scale evaluations and home interventions, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe mental disorders, cardiovascular and cerebrovascular diseases, or other severe physical illnesses. 2.Individuals implanted with electronic devices such as cardiac pacemakers. 3.Females during pregnancy or lactation period 4.Patients with ear diseases, malformations or skin damage that preclude electrode placement. 5.Insomnia caused by objective factors (untreated internal diseases, mental disorders) or substance-related factors (including but not limited to caffeine, alcohol, tobacco, etc.). 6.Patients diagnosed with other types of sleep disorders besides insomnia disorder. 7.Those who are currently using, or have used within 2 weeks before enrollment, medications that may significantly affect sleep architecture and neuroelectrophysiological activities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour average systolic/diastolic blood pressure;Emotional indicators;Quality of Life;Circadian blood pressure decline rate; | — |
Countries
China
Contacts
Public ContactDengdeng Feng
Department of Internal Medicine, Hefei Cancer Hospital,Chinese Academy of Sciences
Outcome results
None listed