Efficacy of acupuncture on glucocorticoid-induced insomnia: study protocol for a randomized controlled trial assessed by polysomnographic parameters and 5-HT.

BACKGROUND: Glucocorticoids are extensively utilized in clinical medicine, yet their therapeutic benefits are often accompanied by adverse effects, among which insomnia is particularly prevalent. This sleep disturbance not only compromises treatment efficacy but also significantly diminishes patients' quality of life. Notably, no targeted therapeutic interventions are available that specifically address glucocorticoid-induced insomnia. Acupuncture therapy has potential as a promising complementary approach for managing sleep disorders in patients receiving glucocorticoid treatment. METHODS: This study presents a randomized, sham-controlled clinical trial protocol. A total of 76 patients with glucocorticoid-induced insomnia will be randomly assigned to either the acupuncture group or the sham acupuncture group. The primary outcome is the change in Pittsburgh Sleep Quality Index total score from baseline to post-intervention. The key secondary outcomes are the changes from baseline to post-intervention in the Insomnia Severity Index score, polysomnography-derived total sleep time, and polysomnography-derived sleep efficiency. Other exploratory outcomes include additional polysomnographic parameters, actigraphy parameters, peripheral 5-hydroxytryptamine levels, emotional status, and daytime functioning. DISCUSSION: This trial will evaluate the efficacy and safety of acupuncture for glucocorticoid-induced insomnia and explore potential physiological mechanisms in this specific patient population. CLINICAL TRIAL REGISTRATION: https://itmctr.ccebtcm.org.cn/mgt/search, identifier: ITMCTR2025000220.