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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Short-term Insomnia
• Intervention / Treatment: Other: Acupuncture; Drug: Estazolam

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huanqin Li, Doctor; Phone Number: 0086+13521663936; Email: hqin_li@163.com
• Study Contact Backup: Name: ZiYi Wang, Master; Phone Number: 0086+18801316757; Email: 1729644336@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Hospital of Traditional Chinese Medicine
      • Sub-Investigator: Xiang Li
      • Contact: Huanqin Li
      • Principal Investigator: Huanqin Li
      • Sub-Investigator: Qiuyang Hong
      • Sub-Investigator: Xuewen Mao
      • Sub-Investigator: Zhaoyang Huang
      • Sub-Investigator: Xin Zhao
      • Sub-Investigator: Yue Deng
      • Sub-Investigator: Ziyi Wang
      • Sub-Investigator: Yeqing He
      • Sub-Investigator: Yichen Fei
      • Sub-Investigator: Xiaoyu Yan
      • Sub-Investigator: Qian Liu
      • Sub-Investigator: Mingyang Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meet diagnostic criteria for short-term insomnia according to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5th ed (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2017，a predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: 1)Difficulty initiating sleep. 2). Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. 3)Early-morning awakening with inability to return to sleep. 4)The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. The sleep difficulty occurs at least 3 nights per week. The duration of the sleep difficulty is 1 week to 3 months.
2. Experienced insomnia between 1 weeks and 3 months before the start of project.
3. Age: patients between 18 and 70 years old.
4. Patients who agreed to participant in this trial and assigned the informed consent.

Exclusion Criteria:

1. People with other DSM-IV Axis I, Axis II mental disorders or substance abuse/dependence;
2. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, hypertension, digestive system, hematopoietic system, liver, kidney, or severe anxiety and depression;
3. Caused by alcohol or drugs;
4. Pregnant or lactating women;
5. Easy to combine infection and bleeding; 6.1 Patients who have used psychotropic drugs, such as antidepressants, mania drugs or other drugs used to treat psychosis, in the last month, and patients who have taken sleeping pills in the last 1 month;

7. Those who cannot cooperate with treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Chou's Tiaoshen" acupoints group; Acupuncturing"Chou's Tiaoshen" acupoints,"Chou's Tiaoshen" acupoints is derived from the experience of Zhou Dean, anational famous traditional Chinese medicine doctor in our department.	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.; Other Names: Dry needle
Active Comparator: Estazolam group; Estazolam is a drug commonly used in the treatment of insomnia	Drug: Estazolam; Participants will take estazolam 1mg 30min prior to bedtime everyday. The course of treatment is two weeks.; Other Names: Estazolam pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Eighteen individual items generate seven "component" scores: subjective sleep quality (SQ), sleep-onset latency (SOL), total sleep time (TST), habitual sleep efficiency (SE), sleep disturbances ( Dyssomnia), use of sleeping medication, and daytime dysfunction (DD).The cumulative component score is the PSQI total score ranging from 0 to 21, higher scores indicates worse sleep quality.	PSQI will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Polysomnography (PSG) is a classic instrument for detecting sleep conditions.The following data can be obtained by PSG monitoring: total sleep time, sleep latency, The percentage of time spent in each sleep stage. PSG is of great value for the degree and differential diagnosis of insomnia.	PSG will be recorded in 10 randomly selected patients in each group before treatment and 14 days after treatment.
Heart Rate Variability (HRV)	The degree and regularity of heart rate changes can be reflected by measuring the variability of continuous normal R-R interphase changes by dynamic elctrocardiogram, so as to judge its impact on cardiovascular activities, which can reflect the activity of autonomic nervous system and quantitatively evaluate the balance of sympathetic and vagal nerve tension.	HRV will be recorded 3 times, before treatment, at the 14th day and 28th day after treatment.
Concentration of serum cortisol	Serum cortisol is elevated during stress, which can reflect excessive arousal, and if the brain is constantly under high stress, may lead to long-term elevated cortisol levels.	Serum cortisol will be recorded 2 times, before treatment, and at the 14th day , 28th day after treatment, and the measurement time was fixed at 8 am each time.
Fatigue Scale	The fatigue scale(FS) consists of 14 items, each of which is a fatigue-related question, reflecting both physical fatigue and mental fatigue. The highest total score is 14 points, the lowest is 0 points, and the higher the score is, the more serious the fatigue is.	FS will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Ford Insomnia Response to Stress Test Chinese version，FIRST	FIRST is a self-reporting tool including nine items designed to assess sleep response, The minimum total score is 9 and the maximum is 36. Higher scores on the FIRST indicate a more highly reactive sleep system.	FIRST will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Traditional Chinese medicine symptom scoring Scale	The TCM symptom scoring scale consists of five items with a minimum score of 0 and a maximum score of 30, reflecting the five core symptoms of insomnia, with higher scores indicating more severe symptoms.	TCM symptom score will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.

Collaborators and Investigators

• Sponsor: Beijing Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Huanqin Li, Doctor, Beijing Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Estazolam
• Other Study ID Numbers: LYZD202203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to publish a protocol of this trial in about 6-8 months after the registration, and one paper of the trial including results in a high-impact peer reviewed journal in one year after the trial. About two years after the end of this trial and our open publication of the result, the primary data and type of analysis will be available for 5-10 years until data updated by a more specific study with larger number of participants. Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email. We provide the collected primary data without no real information of participants, all the data sequence will be numbered instead of real names.
• IPD Sharing Time Frame: About two years after the end of this trial and our open publication of the result, the primary data and type of analysis will be available for 5-10 years until data updated by a more specific study with larger number of participants.
• IPD Sharing Access Criteria: Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No