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Observation on Clinical Efficacy of "Regulating Shen with Acupuncture" for Chronic Insomnia with Mild Cognitive Impairment

Observation on Clinical Efficacy of "Regulating Shen with Acupuncture" for Chronic Insomnia with Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001325
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-01

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 dysfunction

Interventions

Control Group:CBT-I combined with shallow acupuncture at non-effective acupoints.
Treatment group:CBT-I combined with the "Xingnao Kaiqiao" needle method

Sponsors

Chengdu Integrated TCM&Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic insomnia and mild cognitive impairment as described above; (2) Age between 40 and 80 years old; (3) Pittsburgh Sleep Quality Index (PSQI) score >7 points; (4) Cognitive function assessment: Montreal Cognitive Assessment (MoCA) scale: illiterate group <13 points, primary school group =19 points, junior high school and above group =24 points; Clinical Dementia Rating (CDR) =0.5 points; (5) No significant vision or hearing problems; have certain communication skills, able to cooperate; at the same time, each patient has one family liaison officer participating, who has a junior high school education or above, can use a smartphone, and has the time and willingness to participate in the patient's health management; (6) Informed consent and willing to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Those diagnosed with obstructive sleep apnea, restless legs syndrome, or other sleep disorders; (2) Secondary insomnia caused by substance dependence or organic diseases; (3) Those meeting criteria for alcohol or other substance use disorders; (4) History of traumatic brain injury, severe cardiovascular, cerebrovascular, hepatic, or renal diseases, or other serious somatic diseases, or currently in the unstable phase of chronic somatic diseases; (5) Those with a clear history of psychiatric disorders; (6) Those with hemostatic disorders or other contraindications for acupuncture; (7) Those who have received other treatments for insomnia or MCI, or interventions affecting cognitive function within the past month; (8) Patients currently participating in or planning to participate in other studies on insomnia or cognitive impairment interventions outside of this research.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;Sleep Duration;Mini-Mental State Examination;brain-derived neurotrophic factor;Tau protein;

Countries

China

Contacts

Public ContactHou Tian Shu

Chengdu Integrated TCM&Western Medicine Hospital

757396195@qq.com13880685086

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026