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Acupuncture for chronic insomnia with mild cognitive impairment: protocol for a randomized controlled trial
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DOI：10.3389/fneur.2026.1790480.png)
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Abstract
En 中文
IntroductionChronic insomnia frequently coexists with mild cognitive impairment (MCI) and may aggravate cognitive and daytime dysfunction. Pharmacological treatments can cause adverse effects; and cognitive behavioral therapy for insomnia (CBT-I) may be limited by resource and accessibility barriers. Acupuncture is a commonly used non-pharmacological intervention; but sham-controlled evidence in patients with chronic insomnia and comorbid MCI remains limited. This protocol describes; to our knowledge; one of the few sham-controlled randomized trials specifically targeting this comorbid population.Methods and analysisThis is a single-center; participant- and assessor-blinded; sham-controlled; parallel-group randomized clinical trial. Eighty-two participants with chronic insomnia and MCI will be randomized in a 1:1 ratio to an acupuncture group or a sham-acupuncture group. Both groups will receive 10 sessions over approximately 4 weeks; followed by 1-week and 1-month follow-up assessments; total participation will last approximately 8–9 weeks. The single primary endpoint is the between-group difference in change in Pittsburgh Sleep Quality Index (PSQI) total score from baseline to post-treatment (week 4). Key secondary outcomes are the Insomnia Severity Index (ISI); Montreal Cognitive Assessment-Basic (MoCA-B); and Mini-Mental State Examination (MMSE). Other secondary outcomes include polysomnography (PSG); activities of daily living (ADL); executive-function tests (DST; SCWT; TMT); mood symptoms (BAI; BDI); daytime functioning (FSS; ESS); feasibility/acceptability indices; and safety. Resting-state electroencephalography (EEG) outcomes are exploratory. The primary analysis will use the full analysis set and a repeated-measures linear mixed-effects model.Clinical trial registrationInternational Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/); Identifier ITMCTR2025002221.
Keywords:
acupuncture
protocol
chronic insomnia
a randomized controlled trial
mild cognitive
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