Clinical trial NCT06212934: "Chou's Tiaoshen" Acupoints for Short-term Insomnia.
Official title: "Chou's Tiaoshen" Acupoints for Short-term Insomnia: A Multicenter, Randomized, Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Short-term Insomnia
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: PSQI will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Secondary outcomes:
measure: Polysomnography
timeFrame: PSG will be recorded in 10 randomly selected patients in each group before treatment and 14 days after treatment.
measure: Heart Rate Variability (HRV)
timeFrame: HRV will be recorded 3 times, before treatment, at the 14th day and 28th day after treatment.
measure: Concentration of serum cortisol
timeFrame: 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.
measure: Fatigue Scale
timeFrame: FS will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
measure: Ford Insomnia Response to Stress Test Chinese version，FIRST
timeFrame: FIRST will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
measure: Traditional Chinese medicine symptom scoring Scale
timeFrame: TCM symptom score will be recorded 3 times, before treatment, and at the 14th day , 28th day after treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Huanqin Li, Doctor
role: STUDY_CHAIR
References: