Frontiers in neurology · 2026
Acupuncture for chronic insomnia with mild cognitive impairment: protocol for a randomized controlled trial.
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Jia Xueqian, Zhou Gongyue, Shen Pei, Lin Sangyi, Zhou Haijiang, Xu Fu, Jiang Shuo, Wang Cong
Аннотация
INTRODUCTION: Chronic 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 ANALYSIS: This 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 REGISTRATION: International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/), Identifier ITMCTR2025002221.
METHODS AND ANALYSIS: This 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 REGISTRATION: International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/), Identifier ITMCTR2025002221.