NCT06212934

"Chou's Tiaoshen" Acupoints for Short-term Insomnia.

"Chou's Tiaoshen" Acupoints for Short-term Insomnia: A Multicenter, Randomized, Controlled Clinical Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the curative effect of "Chou's Tiaoshen" acupoints in short-term insomnia and the explore the possible mechanism of the action. The main questions it aims to answer are: * Whether the curative effect of caupuncturing"Chou's Tiaoshen" acupoints in the treatment of short-term insomnia is not inferior to that of Esazolam. * What is the possible mechanism of acupuncture "Chou's Tiaoshen"acupoints for short-term insomnia. Participants with short-term insomnia who met the criteria will be randomly assigned to "Chou's Tiaoshen"acupoints group and Esazolam group. Polysomnography, heart rate variability, cortisol and related scales will be measured before and after treatment to detect the changes in symptoms and signs before and after treatment.

Detailed description

The incidence of short-term insomnia is high. In clinical practice, due to patients insufficient understanding of the severity of short-term insomnia and the side effects of drug treatment, the treatment of short-term insomnia has not made breakthrough progress, and some patients may turn into chronic insomnia, which is more harmful. There is a growing consensus that short-term insomnia is a hyperarousal disorder associated with high sleep reactivity. "Chou's Tiaoshen" acupoints is derived from the experience of Zhou Dean, a national famous traditional Chinese medicine doctor in our department, and the main points are selected: Baihui (DU20), Shenting (DU24), Sishencong (EX-HN1), Shenmen (HT7), Neiguan (PC6), and Sanyinjiao (SP6), the acupuncture method has achieved good clinical efficacy in the early insomnia research, which can improve the waking state of insomnia patients during the day and improve the sleep quality at night. In order to further verify the efficacy of "Chou's Tiaoshen" acupoints in the treatment of short-term insomnia, explore the possible mechanism of action, discover the physical characteristics of patients with short-term insomnia, and explain the connotation of "Chou's Tiaoshen" acupoints, this clinical study is conducted. 96 patients with short-term insomnia who meet the inclusion criteria will be selected and divided into the "Chou's Tiaoshen" acupoints group and the oral esazolam group according to the principle of random allocation. The study will be conducted in the acupuncture and moxibustion Department of Beijing Hospital of Traditional Chinese Medicine and Shunyi Hospital of Beijing Hospital of Traditional Chinese Medicine. Pittsburgh Sleep Scale (PSQI) assessment, polysomnography (PSG, some subjects), heart rate variability (HRV) monitoring, serum cortisol measurement will be performed before and after treatment. Ford Insomnia Stress Response Test (FIRST) scale, Daytime function Scale and Chinese Medicine Symptom Score Scale will be evaluated to evaluate the efficacy and explore the mechanism.

Conditions

• Short-term Insomnia

Interventions

Type	Name	Description
OTHER	Acupuncture	"Chou's Tiaoshen" acupoints includes Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1), Sanyinjiao (SP-6), Shenmen (HT-7) . Using stainless steel needles (0.32×40)mm, HuaTuo, China). Then some other points like, Danzhong(CV-17), Daling(PC-7), Taixi (KI-3), Qihai (CV-6), Taichong (LR3), and Qiuxu(GB-40) are chosen. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1) are punctured at a depth of 20-25mm obliquely. Sanyinjiao (SP-6) and Shenmen (HT-7) are inserted 15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known as "De Qi"; Technique: Mild reinforcing and attenuating, retaining the needle for 30minutes. The treatment will be givenonce a day and 5 times a week in weekdays, the course will last two weeks.
DRUG	Estazolam	Participants will take estazolam 1mg 30min prior to bedtime everyday. The course of treatment is two weeks.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: China