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Clinical evaluation and mechanism study of fNIRS-based acupuncture intervention for chronic insomnia with mild cognitive impairment

A randomized controlled study of acupuncture for the treatment of chronic insomnia with subjective cognitive decline or with mild cognitive impairment

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076182
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-09-27
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic insomnia with mild cognitive impairment

Interventions

acupuncture group:acupuncture
subjects with chronic insomnia alone group:none

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet ICSD-3 diagnostic criteria for chronic insomnia; and have a Pittsburgh Sleep Quality Index score of >7; (2) Meet diagnostic criteria for mild cognitive impairment; (3) Be of any gender, aged 50-75 years, and right-handed; (4) Had not received any acupuncture-related interventions in the month prior to enrollment; (5) Be able to communicate normally and actively cooperate with the treatment; (6) Voluntary enrollment and signing an informed consent form; The above conditions need to be fulfilled simultaneously to be included in this study. Inclusion criteria for healthy subjects (1) Any gender, age 18 to 75 years old, right-handed; (2) Energetic, optimistic, positive attitude, able to work and live with ease; (3) Good sleep, adequate rest, no cognitive function decline changes; (4) Appropriate body mass, well-proportioned, well-coordinated, and easy to walk; (5) No history of heart, liver, kidney, and other important organ-related diseases and other chronic diseases; (6) Voluntarily participate in this trial and sign an informed consent form. Inclusion criteria for subjects with chronic insomnia alone (1) Meet ICSD-3 diagnostic criteria for chronic insomnia; and have a Pittsburgh Sleep Quality Index score > 7; (2) No changes in cognitive decline; (3) Are of either sex, 50 to 75 years of age, and right-handed; (4) Have the ability of independent daily life, can carry on normal communication and actively cooperate with the treatment; (5) Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined severe cardiovascular and cerebrovascular diseases, severe hepatic and renal insufficiency, severe infectious diseases, malignant tumor, blood disease patients; (2) Pregnant or lactating women; (3) Patients who are allergic to metal, or patients with severe skin lesions at the site to be needled; (4) Those who are participating in other research projects. Those who meet any of the above criteria are excluded.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment;Insomnia Severity Index;Functional Near-Infrared Spectroscopy;

Secondary

MeasureTime frame
Mini Mental Status Examination;Patient Health Questionnaire;Generalized Anxiexy Disorde;Apathy Evaluation Scale;SF-12 Health Survey;

Countries

China

Contacts

Public ContactMa Tingting

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

6080934@qq.com+86 135 5008 6707

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026