Sedative and Hypnotic Effects Induced by EA
EA Induces Sedative and Hypnotic Effects by Detecting BIS Value and MRI.
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedAugust 19, 2014
August 1, 2014
1.9 years
January 7, 2013
August 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BIS value
The primary outcome is assessing whether BIS value reduce during electroacupuncture stimulation.
30 minutes
Study Arms (1)
Electroacupuncture preconditioning
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Must be able to go with EA
- Can not have any disease
You may not qualify if:
- Overworked recently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (1)
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.
PMID: 36741778DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Wang, Dr.
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of anesthesijology
Study Record Dates
First Submitted
January 7, 2013
First Posted
July 11, 2013
Study Start
September 1, 2011
Primary Completion
August 1, 2013
Study Completion
May 1, 2014
Last Updated
August 19, 2014
Record last verified: 2014-08