The effects of the sleep three-needle acupuncture technique on acupoint temperature variations in patients with chronic primary insomnia: a research protocol for a randomized controlled trial

Background: Chronic primary insomnia (CPI) is a commonly encountered clinical disease, the incidence of which has been rising in recent years. In theoretical contexts, the temperature of acupoints in CPI patients is higher than that in unaffected individuals together with concomitant increases in fatigue index and intracranial arterial velocity. Acupuncture has long been used to treat insomnia, and the sleep three-needle acupuncture (STA) approach represents one promising such treatment for this condition. However, no studies to date have assessed the ability of this technique to lower acupoint temperature values or to improve the Insomnia Severity Index (ISI) in treated individuals. Methods: The present exploration is a prospective, randomized, assessor-blind, controlled trial. Totally, 102 adult patients with CPI will be recruited with varying levels of insomnia severity (mild, moderate, severe) and randomized into six equally sized groups. Patients in these groups will then undergo STA together with cognitive-behavioral therapy (CBT) or CBT alone. Acupuncture will be administered for 30min per treatment 2-3 times per week (7 days per cycle) for a maximum of 10 sessions in 4 cycles. All patients underwent CBT for 4 weeks. In addition, 17 patients will be recruited for a healthy control group. Primary outcomes will include acupoint temperature variations and ISI values, while secondary outcomes will include fatigue index values, intracranial arterial velocity, and Pittsburgh Sleep Quality Index (PSQI) values. Discussion: This study aims to test the theory that STA can lower acupoint temperatures and improve ISI values in CPI patients. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), ID: ChiCTR2100048704. Registered on 13/07/2021.