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The clinical efficacy and bioelectrical characteristics of transcutaneous electrical auricular point stimulation at different frequencies in the treatment of insomnia: A clinical study

Registration number：

ITMCTR2024000683

Date of Last Refreshed on：

2024-11-11

Date of Registration：

2024-11-11

Registration Status：

Prospective registration

Public title：

The clinical efficacy and bioelectrical characteristics of transcutaneous electrical auricular point stimulation at different frequencies in the treatment of insomnia: A clinical study

English Acronym：

Scientific title：

The clinical efficacy and bioelectrical characteristics of transcutaneous electrical auricular point stimulation at different frequencies in the treatment of insomnia: A clinical study

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yanan Zhao

Study leader：

Yanan Zhao

Applicant telephone：

18800107425

Study leader's telephone：

18800107425

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zynjiayou425@163.com

Study leader's E-mail：

zynjiayou425@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences 16 Dongzhimennei Xiaojie Dongcheng District Beijing

Study leader's address：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

P24021-PJ21

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/10/8 0:00:00

Contact Name of the ethic committee：

Xie yanming

Contact Address of the ethic committee：

16 Dongzhimennei South Xiaojie Dongcheng District Beijing

Contact phone of the ethic committee：

010-64087789

Contact email of the ethic committee：

chengguochu2021@163.com

Primary sponsor：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

Primary sponsor's address：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences 16 Dongzhimennei Xiaojie Dongcheng District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution
hospital：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

Address：

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences 16 Dongzhimennei Xiaojie Dongcheng District Beijing

Source(s) of funding：

Young Science and Technology Talent Training Programme

Target disease：

chorionic insomnia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

(1) To observe the clinical characteristics and efficacy of taVNS at different stimulation frequencies in the treatment of chronic insomnia (2) The brain functional features of taVNS with different stimulation frequencies were extracted based on EEG information decoding technology

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1) meet the DSM-5 criteria for insomnia disorder; 2) duration of insomnia > 3 months; 3) Age of 18-65 years old right-handed regardless of gender; 4) Pittsburgh Sleep Quality Index (PSQI) score ≥8; 5) Hamilton Anxiety Scale (HAMA) ≤14 and Hamilton Depression Rating Scale (HAMD) ≤17; 6) have not taken any drugs or substances that may affect the nervous system in the past month and have not received acupuncture treatment; 7) can receive electrical auricular acupoint stimulation; 8) sign informed consent.

Exclusion criteria：

1) complicated with serious physical diseases such as coronary heart disease malignant tumor renal failure etc. 2) combined with organic brain diseases; 3) combined with any other mental disorders personality disorders or psychoactive substance abuse or dependence; 4) patients who could not be eluted by using sleep AIDS or acupuncture; 5) pregnant and lactating women; 6) severely damaged ear skin; 7) Unwilling to sign the informed consent form.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2024-11-15

To      2025-06-30

Interventions：

20

Group：

2

Sample size：

Intervention：

Transcutaneous electrical auricular stimulation at 4/20Hz

Intervention code：

20

Group：

1

Sample size：

Intervention：

20Hz transcutaneous auricular electrical stimulation

Intervention code：

20

Group：

3

Sample size：

Intervention：

Transcutaneous electrical auricular stimulation at 20/100Hz

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution/hospital：

Acupuncture and Moxibustion Hospital China Academy of Chinese Medical Sciences

Level of the institution：

Grade 1

Outcomes：

Outcome：

SAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Epworth Sleepiness Scor

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pittsburgh Sleep Quality Index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Resting state EEG

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Insomnia Severity Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

DBAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Peripheral blood omics analysis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Flinders Fatigue Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMA

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fNIRS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

SDS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMD-17

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pittsburgh sleep Quality Index score response rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

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)：

The randomization sequence was generated with the use of SAS 9.4 software by persons who were not involved in the conduct or statistics of the trial. The block size was 6 which means that the patients were enrolled in blocks of 6 adjacent to each other so there were 10 blocks.

Blinding：

IPD sharing：

No

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

no

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

Case Reprot Form

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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