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Effect of qigong on sleep quality and hyperarousal in patients with chronic insomnia: a study protocol for a multi-centre randomised controlled trial.

BMJ open·December 2025·Jiahe Cui, Haotian Han, Hongyu Yue et al.
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Key Finding

This study protocol will compare PLWNT qigong exercise to cognitive behavioral therapy for treating chronic insomnia, measuring sleep quality, hyperarousal states, and multiple biomarkers including stress hormones and brain imaging in 348 patients.

What This Means For You

This is a research study protocol examining whether a specific type of qigong exercise called Prolong Life With Nine Turn-Method (PLWNT) can help people with chronic insomnia sleep better. The study will involve 348 patients from three hospitals in Shanghai, China who will be randomly assigned to either practice PLWNT qigong or receive cognitive behavioral therapy (the standard treatment for insomnia) once weekly for 12 weeks. Researchers will measure sleep quality using validated questionnaires, sleep diaries, and advanced technology like actigraphy devices and brain scans. They'll also examine whether qigong affects hyperarousal—a state of being overly alert that's common in people with insomnia—by measuring stress hormones and brain activity patterns. Additional measurements will assess fatigue levels, anxiety, depression, overall quality of life, digestive symptoms, and gut bacteria composition. Participants will be followed for an additional 8 weeks after treatment ends to see if benefits continue. This study is important because while qigong has been used traditionally in China to improve sleep, there hasn't been rigorous scientific evidence to prove it works for chronic insomnia. The results won't be available for some time since this is just the study protocol, but if successful, it could provide people with insomnia another effective, non-medication treatment option. If you're interested in exploring qigong for sleep problems, seek a qualified practitioner certified in medical qigong or traditional Chinese medicine.

Clinical Notes for Practitioners

This multi-centre RCT protocol aims to evaluate PLWNT qigong versus cognitive behavioral therapy for chronic insomnia in 348 patients across three Shanghai hospitals. The 12-week intervention (once weekly) with 8-week follow-up will assess sleep quality via PSQI as the primary outcome, with secondary measures including Hyperarousal Scale, ISI, MFI-20, HADS, SF-36, and GSRS assessed at baseline, 6 weeks, 12 weeks, and follow-up points. Novel mechanistic assessments include polysomnography, fMRI, actigraphy, gut microbiota analysis, and stress hormone panels (cortisol, ACTH, CRH) measured at baseline and 12 weeks. The study addresses a significant evidence gap regarding qigong's efficacy for insomnia treatment and explores the hyperarousal hypothesis through comprehensive biomarker and neuroimaging evaluation. Results pending, but the rigorous design comparing qigong to an evidence-based control (CBT) rather than waitlist strengthens potential clinical applicability for integrative insomnia management.

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