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Observation on the therapeutic effect of transcutaneous acupoint electrical stimulation with meridian flow on stroke-related circadian dysrhythmia sleep-wake disorders

Registration number：

ITMCTR2024000311

Date of Last Refreshed on：

2024-08-27

Date of Registration：

2024-08-27

Registration Status：

Retrospective registration

Public title：

Observation on the therapeutic effect of transcutaneous acupoint electrical stimulation with meridian flow on stroke-related circadian dysrhythmia sleep-wake disorders

English Acronym：

Scientific title：

Observation on the therapeutic effect of transcutaneous acupoint electrical stimulation with meridian flow on stroke-related circadian dysrhythmia sleep-wake disorders

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Changling Dong

Study leader：

Tian Jun

Applicant telephone：

13972498028

Study leader's telephone：

18995540980

Applicant Fax：

Study leader's fax：

Applicant E-mail：

dclwdh@163.com

Study leader's E-mail：

tianjun@znhospital.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Rehabilitation Department, Zhongnan Hospital of Wuhan University

Study leader's address：

Rehabilitation Department, Zhongnan Hospital of Wuhan University

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Zhongnan Hospital of Wuhan University

Approved by ethic committee：

Approved No. of ethic committee：

2022076

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Zhongnan Hospital, Wuhan University

Date of approved by ethic committee：

2022/4/18 0:00:00

Contact Name of the ethic committee：

Zheng Lei

Contact Address of the ethic committee：

Outpatient Building,11th Floor.NO. 169 Donghu Road, Wuchang District, Wuhan ,Hubei ,China

Contact phone of the ethic committee：

+86-27-67812787

Contact email of the ethic committee：

znyyll@126.com

Primary sponsor：

Zhongnan Hospital of Wuhan University

Primary sponsor's address：

NO. 169 Donghu Road, Wuchang District, Wuhan ,Hubei ,China

Secondary sponsor：

Country：

China

Province：

Hubei

City：

Wuhan

Institution
hospital：

Zhongnan Hospital of Wuhan University

Address：

NO. 169 Donghu Road, Wuchang District, Wuhan ,Hubei ,China

Source(s) of funding：

The funding for this project comes from the horizontal project (1606-25000159), with a total funding of 25000 yuan

Target disease：

Stroke related circadian rhythm disorder sleep wake disorder

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

To observe the clinical effect of meridian flow percutaneous acupoint electrical stimulation on stroke related circadian rhythm sleep-wake disorders (CRSWDs), in order to provide new ideas for the treatment of CRSWDs.

Description for medicine or protocol of treatment in detail：

Sixty-four patients who met the diagnostic criteria for stroke-related CRSWDs admitted to the rehabilitation Department of our hospital from July 2022 to December 2023 were selected as the study objects. According to random number table method, they were divided into the midday injection group (32 cases) and the drug group (32 cases). Based on sleep hygiene education and behavior management, the two groups were divided into two groups. At the same time, Agomelatine, a melatonin receptor agonist, was orally administered 25mg/d. The observation group was given midday percutaneous electrical stimulation therapy, and the control group was given oral dexzopiclone therapy. Two weeks after treatment, the differences of polysomnosis monitoring parameters (sleep efficiency, wake times, sleep latency, total sleep time) and Pittsburgh sleep quality index (PSQI) before and after treatment between the two groups were observed. The 17-item Hamilton depression rating scale (HAMD-17) and Hamilton anxiety scale (HAMA) were evaluated for the two groups of patients. To evaluate the improvement of sleep quality and adverse reactions of patients in the two groups, telephone follow-up was conducted twice in the 2nd and 4th week after discharge, and telephone questionnaire survey was conducted on discharged patients using the Athens Insomnia Scale (AIS), and the sleep and emotional status of patients in the two groups after discharge was observed and compared.

Inclusion criteria

(1)Meeting the diagnostic criteria for stroke and circadian rhythm disorder of sleep; (2)Aged between 35 and 70 years old without cognitive impairment and no cognitive dysfunction, able to fully understand the scale and cooperate with treatment; (3)Understanding and agreeing to join the study and signing a written informed consent form; (4)No allergic reactions to treatment drugs.

Exclusion criteria：

(1) Patients with severe hepatic and renal insufficiency; (2) People with severe cognitive and communication disabilities and those with visual and hearing disabilities; (3) Combined with serious mental illness and other sleep disorders; (4)the skin at the acupoint is damaged; (5)People who have taken sleeping pills or antidepressant anxiety drugs in the past; (6)Patients with peripheral nerve and muscle system disease; (7) Pregnancy, lactation, pregnancy preparation in the near future.

Study execute time：

From 2022-01-01

To      2024-03-31

Recruiting time：

From 2022-06-01

To      2023-12-31

Interventions：

32

Group：

Drug group

Sample size：

Intervention：

On the basis of sleep hygiene education and behavioral management, the melatonin receptor agonist agomelatine was orally administered at a dose of 25 mg/d, while the medication group was given 3 mg of dexmedetomidine orally before bedtime for treatment

Intervention code：

32

Group：

Meridian flow group

Sample size：

Intervention：

On the basis of sleep hygiene education and behavior management, the two groups were treated with melatonin receptor agonist(25mg/d), the Ziwu Liuzhu group was given meridian injection percutaneous electrical

Intervention code：

Total sample size ： 64

Countries of recruitment
and research settings：

Country：

China

Province：

Hubei

City：

Wuhan

Institution/hospital：

Zhongnan Hospital of Wuhan University

Level of the institution：

Third Grade First Class

Outcomes：

Outcome：

Sleep quality

Type：

Primary indicator

Measure time point of outcome：

Before treatment and 2 weeks after treatment

Measure method：

Scale evaluation

Outcome：

12.5%

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

阿森斯失眠量表（AIS）评分

Type：

Additional indicator

Measure time point of outcome：

2 weeks and 4 weeks after patient discharge

Measure method：

Telephone follow-up survey

Outcome：

HAMA score

Type：

Secondary indicator

Measure time point of outcome：

Before treatment and 2 weeks after treatment

Measure method：

Scale evaluation

Outcome：

Sleep efficiency \ wake times \ sleep latency \ total sleep time;

Type：

Primary indicator

Measure time point of outcome：

Before treatment and 2 weeks after treatment

Measure method：

Using a multi-channel sleep recorder for monitoring

Outcome：

HAMD score

Type：

Secondary indicator

Measure time point of outcome：

Before treatment and two weeks after treatment

Measure method：

Scale evaluation

Collecting sample(s)
from participants：

Sample Name：

There is no

Tissue：

Fate of sample 

Others

Note：

Completed

35
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The authors of the study in the Department of Rehabilitation Medicine of Zhongnan Hospital of Wuhan University used statistical software to generate random sequences

Blinding：

IPD sharing：

Yes

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

fter the paper is published, it will be published on the website of China clinical trial registration center

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

Data collection is collected by clinical researchers with CRF, and EpiData database is established for input and data statistics

Data Managemen Committee：

Yes

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

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