chronic insomnia with subjective cognitive decline
Conditions
Interventions
acupuncture group:acupuncture
control group:sham acupuncture
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 50–75 years. 2. Diagnosis of chronic insomnia disorder per International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3TR) criteria and ISI > 10. 3. Having at least 8 years of education. 4. Subjective cognitive concerns including memory-centered complaints as primary concern and persistent distress regarding cognitive decline. 5. Normal cognitive performance on standardized neuropsychological battery. 6. MoCA-B score = 23 for individuals with = 12 years of education, or = 25 for those with > 12 years of education. 7. RBDSQ < 5 and NoSAS < 7. 8. GAD-7 < 10 and PHQ-9 < 10. 9. Right-handed. 10. No use of medications for improving sleep or cognitive function within 1 month. 11. No acupuncture treatment within 6 months. 12. Willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe diseases of the heart, liver, kidneys, blood, and respiratory systems, as well as uncontrolled infectious diseases. 2. A history of severe mental illnesses (such as bipolar disorder, schizophrenia, etc.) or malignant tumors. 3. Localized skin or tissue infection at acupuncture points. 4. Metabolic diseases, such as anemia, thyroid dysfunction, folic acid and vitamin B12 deficiencies, etc. 5. A history of alcoholism or substance use disorder. 6. Contraindications to acupuncture. 7. Unable to cooperate in completing assessments. 8. Any condition or event judged by the principal investigator to potentially affect cognitive function (such as a history of traumatic brain injury, stroke, heart surgery, etc.). 9. Participation in a study involving cognitive assessment within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective Cognitive Decline Questionnaire;Pittsburgh Sleep Quality Index;Montreal Cognitive Assessment;auditory verbal learning test - Huashan version;Generalized Anxiety Disorder Scale;Patient Health Questionnaire-9;Functional Activity Questionnaire;Total Sleep Time;Sleep Efficiency;Sleep Onset Latency;Wake After Sleep Onset; | — |
Countries
China
Contacts
Public ContactYunfei Chen
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed