Insomnia with mild cognitive impairment
Conditions
Interventions
Acupuncture group:Acupuncture
Sham acupuncture group:sham acupuncture
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for chronic insomnia in the ICSD-3; (2) Age = 18 years, gender; (3) No history of sedative-hypnotic drug use prior to entering this study; (4) Pittsburgh Sleep Quality Index (PSQI) total score > 5 points; (5) Montreal Cognitive Assessment (MoCA) score: =13 points for those with no education, =19 points for those with 1-4 years of education, and =24 points for those with =7 years of education; (6) Mini-Mental State Examination (MMSE) score < 24 points; (7) Non-demented patients, i.e., Clinical Dementia Rating (CDR) score = 0.5 points; (8) Activity of Daily Living (ADL) score = 23 points, indicating that activities of daily living are minimally impaired; (9) Right-handed, with normal auditory, visual, and reading comprehension abilities; (10) Voluntary participation, with informed consent signed prior to entering the study.
Exclusion criteria
Exclusion criteria: (1) Those with severe impairment of heart, liver, or kidney functions, as well as diseases of the respiratory, hematological, or mental systems; (2) Patients clinically diagnosed with other sleep disorders; (3) Acute onset (e.g., acute stroke or severe trauma), with a disease duration of less than 6 months; (4) Individuals with severe neurological deficits or significant physical disabilities; (5) Imaging studies (e.g., MRI) showing lesions responsible for other degenerative cognitive disorders or related changes; (6) Presence of conditions that may cause cognitive impairment (e.g., normal pressure hydrocephalus, tumors, etc.); (7) Pregnant or breastfeeding women; (8) Patients with infectious diseases, such as tuberculosis, hepatitis, or HIV/AIDS; (9) Individuals unsuitable for acupuncture treatment, such as those with unhealed injuries, severe skin diseases, or allergic constitutions; (10) Participants in other clinical research studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Insomnia Severity Index;Montreal Cognitive Assessment-Basic;Mini-mental state examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activity of daily living;Digit span test;Stroop color word test;Beck Anxiety Inventory;Beck Depression Inventory;Fatigue Severity Scale;Epworth Sleepiness Scale;EEG; | — |
Countries
China
Contacts
Public ContactWang Cong
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed