Insomnia Disorder
Conditions
Interventions
sham-taVNS Group :Transcutaneous Auricular non-Vagus Nerve Stimulation
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.fulfil the DSM-5 diagnostic criteria for ID; 2.are aged 50-80 years (men or women); 3. no cognitive impairment and ability to cooperate with the scale assessment; 4.Pittsburgh Sleep Quality Index (PSQI) global score =8; 5.no use of any medications or substances that may affect the nervous system or received acupuncture treatment in the past 1 month; 6.physically and psychologically able to tolerate transcutaneous auricular electrical stimulation therapy; 7. provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.severe medical conditions (e.g., coronary heart disease, malignancies, or renal failure); 2.organic brain diseases; 3.mental disorders, personality disorders, or psychoactive substance abuse or dependence; 4.14-item Hamilton Anxiety Scale (HAMA-14) score >14 and 17-item Hamilton Depression Scale (HAMD-17) score >17; 5.pregnancy or lactation; 6.severe skin lesions in the auricular area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Montreal Cognitive Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination;ISI;HAMA;Brain-Derived Neurotrophic Factor;HAMD-17;Heart Rate Variability;ESS;FFS;BC-CCI; | — |
Countries
China
Contacts
Public ContactShuai Zhang
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed