Insomnia
Conditions
Interventions
Experimental Group:Transcutaneous Auricular acupoint Vagus Nerve Stimulation
Control Group:Transcutaneous auricular non-vagal nerve stimulation
Health Group:None
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Elderly insomnia patients: 1) Meet the diagnostic criteria for insomnia disorder according to DSM-5; 2) Insomnia symptoms persist for >3 months; 3) Pittsburgh Sleep Quality Index (PSQI) score =8 points; 4) Age 60-80 years old, with at least 6 years of formal education, gender, right-handed; 5) Have a complaint of memory decline, and British Columbia Cognitive Complaints Inventory (BC-CCI) score =5 points; 6) Have not taken any drugs or substances that may affect the nervous system in the past month, nor received any sleep aids, acupuncture, or cognitive-behavioral therapy; 7) Are willing to undergo auricular acupoint electrical stimulation and MRI scanning; 8) Have normal corrected vision and hearing, and are able to complete sleep-neurocognitive assessments; 9) The participant or their first-degree relative has signed the informed consent form. (2) Healthy subjects: 1) Age 60-80 years old, gender, right-handed; 2) Are willing to undergo MRI scanning; 3) Have no history of sleep disorders, mental illness, or family history of mental illness; 4) Have no history of chronic diseases, somatic diseases, or brain organic diseases; 5) Have normal cognitive function and are able to understand and cooperate to complete the trial process; 6) Voluntarily participate in this project and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Elderly insomnia patients: 1) Clinically diagnosed with severe neurocognitive disorders (meeting DSM-5 diagnostic criteria); 2) Suffering from severe anxiety, severe depression, or other serious neuropsychiatric diseases; 3) With unstable or severe cardiovascular, pulmonary, hepatic, renal, hematopoietic system diseases, or malignant tumors; 4) With hydrocephalus, brain tumors, brain infections, or neurodegenerative diseases; 5) With cognitive decline due to identifiable causes, such as vascular cognitive impairment, Parkinson's cognitive impairment, or diabetic cognitive impairment; 6) Currently taking donepezil, memantine, galantamine, huperzine A, or other medications to improve cognitive function; 7) Unable to complete the sleep-neuropsychological cognitive function scale even after corrected hearing and vision; 8) With severe skin damage on the ears; 9) With contraindications for MRI, such as metal teeth, pacemakers, stents, or claustrophobia. (2) Healthy subjects: 1) Have used drugs or substances that may affect the nervous system, or have undergone acupuncture treatment in the past month; 2) Have engaged in late-night work or shift work in the past two weeks; 3) Have a history of headaches or somatic pain; 4) Have contraindications for MRI, such as metal teeth or claustrophobia; 5) Unable to complete the trial process even after corrected hearing and vision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Auditory Verbal Learning Test-Huashan Version Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Montreal Cognitive Assessment (MoCA) Basic Version Scale;Insomnia Severity Index Scale;British Columbia Cognitive Complaints Inventory;Stroop Color and Word Test;Shape Trails Test A&B;Verbal Fluency Test;Structural Magnetic Resonance Imaging (sMRI);Functional Magnetic Resonance Imaging (fMRI); | — |
Countries
China
Contacts
Public ContactZhang Shuai
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed