NCT03237338

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 24, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 26, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 9, 2021

Status Verified

August 1, 2020

Enrollment Period

3.7 years

First QC Date

July 24, 2017

Last Update Submit

July 7, 2021

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

  • change from baseline brain GABA level at 24 days

    GABA levels in the prefrontal gyrus, occipital gyrus

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

Secondary Outcomes (2)

  • brain functional connectivity

    at the 24th day after acupuncture treatment

  • Wake time after sleep onset (WASO)

    at the 24th day after acupuncture treatment

Study Arms (2)

Insomnia-ture acupuncture

EXPERIMENTAL

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

Procedure: ture acupuncture

Insomnia-sham acupuncture

SHAM COMPARATOR

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

Procedure: sham acupuncture

Interventions

ture acupuncturePROCEDURE

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

Insomnia-ture acupuncture
sham acupuncturePROCEDURE

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

Insomnia-sham acupuncture

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Ran Pang, doctor

CONTACT

861067693481pangrandf@163.com

Li Zhang

CONTACT

861067689644zhanglidf2017@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 2, 2017

Study Start

December 26, 2017

Primary Completion

August 20, 2021

Study Completion

December 31, 2021

Last Updated

July 9, 2021

Record last verified: 2020-08

Locations

CN(1)