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

NCT06212934 | Unknown DMC

• 1 other identifier: LYZD202203
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short-term Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Polysomnography

  PSG will be recorded in 10 randomly selected patients in each group before treatment and 14 days after treatment.

• Heart Rate Variability (HRV)

  HRV will be recorded 3 times, before treatment, at the 14th day and 28th day after treatment.

• Concentration of serum cortisol

  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

  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 will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.

Study Arms (2)

"Chou's Tiaoshen" acupoints group

EXPERIMENTAL

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

Estazolam group

ACTIVE COMPARATOR

Estazolam is a drug commonly used in the treatment of insomnia

Drug: Estazolam

Interventions

Acupuncture OTHER

"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.

Also known as: Dry needle

"Chou's Tiaoshen" acupoints group

Estazolam DRUG

Participants will take estazolam 1mg 30min prior to bedtime everyday. The course of treatment is two weeks.

Also known as: Estazolam pill

Estazolam group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Experienced insomnia between 1 weeks and 3 months before the start of project.
• Age: patients between 18 and 70 years old.
• Patients who agreed to participant in this trial and assigned the informed consent.

You may not qualify if:

• People with other DSM-IV Axis I, Axis II mental disorders or substance abuse/dependence;
• Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, hypertension, digestive system, hematopoietic system, liver, kidney, or severe anxiety and depression;
• Caused by alcohol or drugs;
• Pregnant or lactating women;
• 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;
• \. Those who cannot cooperate with treatment.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Acupuncture Therapy; Estazolam

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Huanqin Li, Doctor

  Beijing Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Huanqin Li, Doctor

CONTACT

0086+13521663936; hqin_li@163.com

ZiYi Wang, Master

CONTACT

0086+18801316757; 1729644336@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 19, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.
• Access Criteria: Anyone who are interested in the trial can ask us to share the primary data by send a requirement through email.

Locations

CN (1)