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The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI

Primary Purpose

Insomnia Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ture acupuncture

sham acupuncture

About this trial

This is an interventional basic science trial for Insomnia Disorder

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months
Must be able to cooperate with cognitive testing and MRI scan

Exclusion Criteria:

Known pre-existing sleep disorder other than chronic insomnia disorder
Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation)
Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems
Clinical diagnosis of AD or Parkinson's neurodegenerative diseases
Moderate or severe psychological illness
Clinical history of stroke or other severe cerebrovascular disease
Clinical history of malignancies disease
Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
Alcohol or drug abuse

Sites / Locations

Dongfang Hospital Affiliated to Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Insomnia-ture acupuncture

Insomnia-sham acupuncture

Arm Description

True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture

Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture

Outcomes

Primary Outcome Measures

change from baseline brain GABA level at 24 days

GABA levels in the prefrontal gyrus, occipital gyrus

Secondary Outcome Measures

brain functional connectivity

functional connectivity between the medial prefrontal cortex and other brain regions

Wake time after sleep onset (WASO)

WASO is the total time of awake occurring between sleep onset and final wake up

Full Information

NCT ID

NCT03237338

First Posted

July 24, 2017

Last Updated

July 7, 2021

Sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Collaborators

Xuanwu Hospital, Beijing, First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT03237338

Brief Title

The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI

Official Title

The Study of Brain GABA and Brain Functional Modulatory Mechanism of Chronic Insomnia Disorder Using Acupuncture at "Combined Magical-door" Acupoints

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 26, 2017 (Actual)

Primary Completion Date

August 20, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Collaborators

Xuanwu Hospital, Beijing, First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Insomnia disorder is one of the major neuropsychiatric diseases which received more attention in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on insomnia symptom. However, the underlying mechanism remains unclear. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA levels between pro- and post-acupuncture treatment in individuals with chronic insomnia disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to determine whether CID patients have altered brain connectivity and network parameter changes. The investigators are also exploring the correlation between cortical GABA levels, fMRI parameter changes and abnormalities in sleep parameters and neuropsychology test in CID patients.

Detailed Description

Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and healthy) will participate in the study. All subjects will undergo a laboratory blood test, physical and neurological examination, polysomnography (PSG) and an extensive battery of neuropsychological assessments. All subjects meeting eligibility criteria for the study will complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and fMRI parameters between the patients and healthy. After randomized acupuncture treatment, investigators will compare brain metabolic and functional parameters to elucidate the neural mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the perspective of neurotransmitters and brain network.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Insomnia-ture acupuncture

Arm Type

Experimental

Arm Description

True acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture

Arm Title

Insomnia-sham acupuncture

Arm Type

Sham Comparator

Arm Description

Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints will be administered on CID patients Intervention: Procedure: true acupuncture

Intervention Type

Procedure

Intervention Name(s)

ture acupuncture

Intervention Description

ture acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks

Intervention Type

Procedure

Intervention Name(s)

sham acupuncture

Intervention Description

Sham acupuncture at the "Magical-door", "Si-shen-cong", "Shen-ting", "Local-cave" acupoints, three times per week and last for 6 weeks

Primary Outcome Measure Information:

Title

change from baseline brain GABA level at 24 days

Description

GABA levels in the prefrontal gyrus, occipital gyrus

Time Frame

at the 2 day before acupuncture treatment and the 24th day after acupuncture treatment

Secondary Outcome Measure Information:

Title

brain functional connectivity

Description

functional connectivity between the medial prefrontal cortex and other brain regions

Time Frame

at the 24th day after acupuncture treatment

Title

Wake time after sleep onset (WASO)

Description

WASO is the total time of awake occurring between sleep onset and final wake up

Time Frame

at the 24th day after acupuncture treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months Must be able to cooperate with cognitive testing and MRI scan Exclusion Criteria: Known pre-existing sleep disorder other than chronic insomnia disorder Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation) Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems Clinical diagnosis of AD or Parkinson's neurodegenerative diseases Moderate or severe psychological illness Clinical history of stroke or other severe cerebrovascular disease Clinical history of malignancies disease Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon) Alcohol or drug abuse

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ran Pang, doctor

Phone

861067693481

pangrandf@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Zhang

Phone

861067689644

zhanglidf2017@126.com

Facility Information:

Facility Name

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Zhang, MD

Phone

861067689644

12. IPD Sharing Statement

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The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI

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