Sedative and Hypnotic Effects Induced by EA

August 17, 2014 updated by: wangqiang, Xijing Hospital

EA Induces Sedative and Hypnotic Effects by Detecting BIS Value and MRI.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Overworked recently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture preconditioning
Procedure: Electroacupuncture

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Qiang Wang, Dr., Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

July 7, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 17, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • wangqiang888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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