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Acupuncture for chronic insomnia with mild cognitive impairment: protocol for a randomized controlled trial
Xueqian Jia1, Gongyue Zhou1,2, Pei Shen1,2
1The First School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China.
Frontiers in Neurology
|July 6, 2026
Summary
This study investigates acupuncture for chronic insomnia with mild cognitive impairment (MCI). It
Area of Science:
- Integrative Medicine
- Neurology
- Sleep Medicine
Background:
- Chronic insomnia often co-occurs with mild cognitive impairment (MCI), potentially worsening cognitive and daytime function.
- Existing treatments for insomnia, such as pharmacotherapy and cognitive behavioral therapy for insomnia (CBT-I), have limitations including adverse effects and accessibility issues.
- Acupuncture presents a non-pharmacological option, but robust sham-controlled trial data for patients with comorbid chronic insomnia and MCI is scarce.
Purpose of the Study:
- To evaluate the efficacy of acupuncture compared to sham acupuncture in treating chronic insomnia in individuals with comorbid mild cognitive impairment.
- To assess the impact of acupuncture on sleep quality, cognitive function, and daytime functioning in this specific patient population.
Main Methods:
- A single-center, participant- and assessor-blinded, sham-controlled, parallel-group randomized clinical trial involving 82 participants.
- Participants were randomized to receive either 10 sessions of acupuncture or sham acupuncture over 4 weeks.
- The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) total score from baseline to week 4; secondary outcomes included cognitive assessments (MoCA-B, MMSE) and insomnia severity (ISI).
Main Results:
- The study is designed to compare the change in PSQI scores between the acupuncture and sham acupuncture groups as the primary endpoint.
- Key secondary outcomes include changes in insomnia severity, cognitive assessments (MoCA-B, MMSE), and other measures of daily function, mood, and sleep via PSG.
Conclusions:
- This trial aims to provide crucial sham-controlled evidence on the effectiveness of acupuncture for chronic insomnia with comorbid MCI.
- Findings are expected to inform clinical practice regarding non-pharmacological treatment options for this complex patient group.
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