NCT01896063

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1.9 years

First QC Date

January 7, 2013

Last Update Submit

August 17, 2014

Conditions

Keywords

Electroacupuncture, Sedation

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

EXPERIMENTAL
Procedure: Electroacupuncture

Interventions

Electroacupuncture preconditioning

Eligibility Criteria

Age24 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

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.

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Qiang Wang, Dr.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

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

Locations