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Study on the Intervention Effect of Electroacupuncture at Tiaoshen Points on Hyperarousal in Patients with Chronic Insomnia and Its Brain Functional Mechanism

Registration number：

ITMCTR2025000495

Date of Last Refreshed on：

2025-03-10

Date of Registration：

2025-03-10

Registration Status：

Prospective registration

Public title：

Study on the Intervention Effect of Electroacupuncture at Tiaoshen Points on Hyperarousal in Patients with Chronic Insomnia and Its Brain Functional Mechanism

English Acronym：

Scientific title：

Study on the Intervention Effect of Electroacupuncture at Tiaoshen Points on Hyperarousal in Patients with Chronic Insomnia and Its Brain Functional Mechanism

Scientific title acronym：

Study subject ID：

2023-JYB-JBQN-032

The registration number of the Partner Registry or other register：

Applicant：

ZHANGZIYAN

Study leader：

XINGJIA

Applicant telephone：

15613358738

Study leader's telephone：

13810680063

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zhangziyanzzzy@163.com

Study leader's E-mail：

dfyyxingjia@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 11 North Third Ring Road East Chaoyang District Beijing

Study leader's address：

No. 6 Fangxingyuan Phase 1 Fangzhuang Fengtai District Beijing

Applicant postcode：

100105

Study leader's postcode：

100078

Applicant's institution：

Dongfang Hospital Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

JDF-IRB-2024033202

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of Dongfang Hospital Beijing University of Chinese Medicine

Date of approved by ethic committee：

2025/1/20 0:00:00

Contact Name of the ethic committee：

XIAYUN

Contact Address of the ethic committee：

Room 444 South Branch East Building Dongfang Hospital No. 6 Fangxingyuan Phase 1 Fangzhuang Fengtai District Beijing

Contact phone of the ethic committee：

01067654807

Contact email of the ethic committee：

dfyyec@126.com

Primary sponsor：

Dongfang Hospital Beijing University of Chinese Medicine

Primary sponsor's address：

No. 6 Fangxingyuan Phase 1 Fangzhuang Fengtai District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Fengtai District

Institution
hospital：

Dongfang Hospital Beijing University of Chinese Medicine

Address：

No. 6 Fangxingyuan Phase 1 Fangzhuang Fengtai District Beijing

Source(s) of funding：

Beijing University of Chinese Medicine unveiled the leading project

Target disease：

Chronic insomnia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To explore the intervention effect and brain function mechanism of electroacupuncture Tiaoshen Point on excessive awakening of chronic insomnia patients

Description for medicine or protocol of treatment in detail：

This study can be divided into two parts. The first part intends to adopt a randomized single-blind controlled design to divide patients with chronic insomnia accompanied by hyperarousal into three groups: electroacupuncture at Shen points sham electroacupuncture at Shen points and electroacupuncture at sham Shen points. Before and after treatment the clinical efficacy will be evaluated through neurobehavioral scales (including the Pittsburgh Sleep Quality Index PSQI Epworth Sleepiness Scale ESS Pre-Sleep Arousal Scale PSAS Hyperarousal Scale HAS Patient Health Questionnaire-9 PHQ-9 and Generalized Anxiety Disorder Scale GAD-7). The key scientific question to be answered is whether electroacupuncture at Shen points has a definite clinical effect on patients with chronic insomnia accompanied by hyperarousal rather than a placebo effect. The second part intends to adopt a mixed experimental design which includes both a cross-sectional comparison of patients receiving electroacupuncture and sham acupuncture and a longitudinal comparison of the treatment course. The current advanced fNIRs technology will be used to evaluate brain network connections and brain functions. fNIRs is a non-invasive neuroimaging technique that provides technical support for detecting and analyzing brain oxygen signals and can monitor changes in the concentrations of local oxygenated hemoglobin (Δ[HbO2]) and deoxygenated hemoglobin (Δ[HHb]). In this study it is planned to use the continuous-wave 82-channel fNIRS system (NirSmart) for hyperscanning to record near-infrared data. Both groups of subjects need to complete the fNIRS whole-brain resting-state task and prefrontal task-state assessment (using the VFT and n-back paradigms for detection) before treatment. Data collection for the corresponding tasks will be conducted for the three groups of patients before treatment immediately after the first treatment (immediate treatment effect) and after 2 weeks of treatment. The dynamic exploration of the therapeutic mechanism of electroacupuncture at Shen points for chronic insomnia will be carried out. Before and after treatment peripheral serum GABA GLu MT IL-1β IL-4 IL-6 IL-10 TNF-α TGF-β and INF-γ and other related indicators will be measured to explore the mechanism of overactivation and inflammation induction from the central to the peripheral nervous-endocrine-inflammatory network in combination with neurofunctional assessment thereby inducing various psychosomatic diseases. The key scientific question to be answered is whether electroacupuncture at Shen points can comprehensively improve the sleep quality daytime function and emotional state of patients with chronic insomnia by regulating the hyperarousal mechanism and lay the foundation for further prevention and treatment of psychosomatic diseases through sleep regulation.

Inclusion criteria

(1) Meeting the diagnostic criteria for chronic insomnia disorder; (2) PSQI score ≥ 7; HAS score ≥ 32; (3) Age ranging from 18 to 65 years old; (4) Capable of cooperating with all scale assessments and sample collections; (5) Having signed the informed consent form.

Exclusion criteria：

(1) Patients suffering from malignant tumors and serious physical diseases such as heart liver kidney and nervous system; (2) Patients with secondary insomnia caused by anxiety depression and other mental disorders; (3) People with substance use disorders (including alcohol tobacco caffeine sedatives psychoactive drugs etc.) Addiction or abuse); (4) SQ ≥5 points; SBQ ≥3 scores; IRLS ≥10 score; (5) long-term use of sedative sleeping pills and antidepressants and other psychotropic drugs; (6) GAD-7≥10 score; PHQ-9≥10 scores; (7) Women during pregnancy lactation and preparation for pregnancy; Subjects who meet any of the above criteria will be excluded.

Study execute time：

From 2023-06-01

To      2025-12-01

Recruiting time：

From 2025-03-20

To      2025-12-01

Interventions：

29

Group：

Electroacupuncture Tiaoshen point group

Sample size：

Intervention：

Acupuncture Baihui Shenmen Neiguan except Baihui are double-sided point selection after entering the needle Baihui Shenmen Neiguan is connected with the positive and negative electrodes of the electric needle. Keep the needle for 30min each time and intervene 5 times a week for 2 weeks

Intervention code：

29

Group：

Electroacupuncture fake tiaoshen point group

Sample size：

Intervention：

Baihui Shenmen Neiguan beside the non-meridian non-collaterals shallow thorn. Needle selection electroacupuncture site treatment frequency and cycle were the same as Tiaoshen point group.

Intervention code：

29

Group：

Fake electroacupuncture Tiaoshen point group

Sample size：

Intervention：

After acupuncture Baihui Shenmen and Neiguan electroacupuncture is not treated in essence only connected with electroacupuncture no electricity in which the choice of acupuncture point location treatment frequency and cycle are the same as that of electroacupuncture Tiaoshen point group.

Intervention code：

Total sample size ： 87

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Fengtai District

Institution/hospital：

Dongfang Hospital Beijing University of Chinese Medicine

Level of the institution：

Third class first class

Outcomes：

Outcome：

fNIRS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSQI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSAS HAS ESS PHQ-9 GAD-7

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TESS

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Serological mechanism index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

In this study a third party generated a random assignment plan through a computer program sealed the random number and the corresponding treatment plan into an opaque envelope and observed that doctors selected the number according to the order of patient enrollment and selected the treatment plan with the corresponding code. The drug number would remain unchanged throughout the trial.

Blinding：

Single blind

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

无

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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