Acupuncture for chronic insomnia with mild cognitive impairment: protocol for a randomized controlled trial.

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.