Sedative and Hypnotic Effects Induced by EA

Bypass Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896063
• Other study ID #: wangqiang888
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2013
• Last updated: August 17, 2014
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Years to 35 Years

Eligibility

Inclusion Criteria:

• Must be able to go with EA

• Can not have any disease

Exclusion Criteria:

• Overworked recently

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bypass Complications

Intervention

Procedure:
• Electroacupuncture

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS value	The primary outcome is assessing whether BIS value reduce during electroacupuncture stimulation.	30 minutes	No