Sedative and Hypnotic Effects Induced by EA | NCT01896063

Studies
Sedative and Hypnotic Effects Induced by EA

NCT01896063

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Aug 19, 2014Estimated

Enrollment

45Actual

Phase

Phase 1

Conditions

Bypass Complications

Interventions

Electroacupuncture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Aug 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Jan 7, 2013

First Submission Date that Met QC Criteria

Jul 7, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2014

Last Update Posted Date

Aug 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Insomnia is a common clinical disease.The serious patients could not sleep all night, often accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental burden of insomnia patients and seriously affected the normal work and quality of life of patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs, mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse reactions, including resistance, dependence and addiction. Many articles indicate that electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic effect and avoid many adverse reactions and side effects. Then there are no more objective indicators to affirm that which part of brain takes place the appropriate changes when electroacupuncture induces the sedative effect. So we designed this experiment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electroacupuncture preconditioning	Experimental		Procedure: Electroacupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electroacupuncture	Procedure		Electroacupuncture preconditioning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BIS value	The primary outcome is assessing whether BIS value reduce during electroacupuncture stimulation.	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to go with EA
Can not have any disease

Exclusion Criteria:

Overworked recently

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qiang Wang, Dr.	Xijing Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shaanxi	710032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36741778	Derived	Lu Z, Huo T, Deng J, Guo F, Liu K, Liu P, Wang Q, Xiong L. Transcutaneous electrical acupoint stimulation induced sedative effects in healthy volunteers: A resting-state fMRI study. Front Hum Neurosci. 2023 Jan 19;16:843186. doi: 10.3389/fnhum.2022.843186. eCollection 2022.

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D015670	Acupuncture Therapy
D000529	Complementary Therapies