Effect of chrono-acupuncture on insomnia—A randomized controlled trial research protocol (Preprint)

BACKGROUND Insomnia is a widespread sleep disorder that significantly affects human health. Insomnia can result in depression, anxiety, and some other symptoms, which present a considerable challenge in clinical practice worldwide[1-2]. Traditional Chinese Medicine(TCM) offers an alternative approach to treating insomnia, and chrono-acupuncture stands out as a promising therapy in this regard. By administering acupuncture at specific time points, chrono-acupuncture aims to regulate the body's biological rhythms, as well as the flow of Qi and blood, potentially providing relief from insomnia symptoms. By leveraging the principles of TCM and the targeted timing of acupuncture stimulation, researchers hope to uncover new insights into the treatment of insomnia and potentially offer an alternative or complementary approach to managing this challenging sleep disorder. OBJECTIVE The purpose of this study is to evaluate the therapeutic effect of acupuncture on insomnia at different hours based on Xuanfu theory and Ying-Wei theory. At the same time, it aims to study the difference between acupuncture and drug treatment of insomnia. METHODS This protocol is a single-center, randomized, controlled trial. 105 eligible subjects will be included in this protocol, and the insomnia patients will be randomly divided into three groups according to the ratio of 1:1:1: control group, 7-9 am acupuncture group and 5-7 pm acupuncture group. RESULTS The results of this protocol will be published in the form of a paper in relevant journals after the experiment is completed. CONCLUSIONS Outcomes All results will be analyzed before treatment, after the end of the first week of treatment, after the end of the third week of treatment, and after the third week of treatment. From this study, we believe that acupuncture in insomnia patients at 7-9 am is better than acupuncture at 5-7 pm. At the same time, the curative effect of the acupuncture group was better than that of the drug control group. Primary outcome PSG: The researchers used PSG to monitor the sleep of the subjects, recording their total sleep time, sleep latency, Rapid Eye Movement(REM) sleep time, wake time, and sleep efficiency. Secondary outcomes (1) PSQI: This scale is mainly used to evaluate the subjects' sleep quality, sleep duration, sleep latency, sleep efficiency, sleep disorder, daytime function, sleep medication, and other 7 items. The full score of all items together is 21 points. The higher a subject's score, the worse their sleep quality; On the contrary, the lower his score, the better his sleep quality. (2) HAMA, HAMD: This scale consists of two subscales of anxiety and depression, including 14 items, and the total score of the items ranges from 0 to 21 points. If a subject scores more than 7 points, it indicates that the subject has symptoms of anxiety or depression. (3) AIS: This scale includes 8 items, and the total score of the items is between 0 and 24 points. When the total AIS score <4 is classified as no sleep disorder, the total AIS score between 4 and 6 is classified as suspicious insomnia, and the total AIS score >6 is classified as insomnia. (4) Neurotransmitter levels that need to be evaluated include Brain-derived Neurotrophic Factor(BDNF) and 5-hydroxytryptamine(5-HT). To do this, the researchers will collect 4ml of venous blood from the subjects in the morning, when they are fasting, and use enzyme-linked immune sorbent assay(ELISA) to measure these two indicators. CLINICALTRIAL Ethics approval was received from the Medical Ethics Committee of the Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University, Luzhou, Sichuan, China (No. 2022YFS0613-B4). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.