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Acupuncture for Insomnia: a Randomized Controlled Trial (AI-RCT)

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DU20 and HT7 combination
DU20 and SP6 combination
DU20 and SA combination
Sponsored by
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring acupoints, insomnia, acupuncture, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
  • PSQI score >7
  • AIS score ≥6
  • SDS ≤60
  • SAS ≤60
  • Age between 18 and 65 years old
  • Not involved in other clinical trial in the lasted 6 months before screening
  • Have the ability to write the informed consent.

Exclusion Criteria:

  • Breathing-related sleep disorders
  • Circadian rhythm sleep-wake disorders
  • Medication-induced sleep disorder
  • Substance induced sleep disorders,such as alcohol, coffee, strong tea
  • Secondary insomnia caused by systemic diseases or caused by external environment disturbance
  • Pregnant or lactating women
  • Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases
  • Advanced malignant tumor or other serious debilitating diseases
  • Location of acupoints combined with infection and bleeding
  • Declined to acupuncture
  • Couldn't provide the written informed consent.

Sites / Locations

  • Second Hospital of Hunan University of Chinese Medicine
  • First Hospital of Hunan University of Chinese Medicine
  • Hengyang hospital of Hunan University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Sham Comparator

Arm Label

DU20 and HT7 combination

DU20 and SP6 combination

DU20 and SA combination

Arm Description

combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).

combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).

combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.

Outcomes

Primary Outcome Measures

Pittsburgh sleep quality index (PSQI)

Secondary Outcome Measures

Athens Insomnia Scale (AIS)
Short Form 36-item Health Survey(SF-36)
Self-anxiety scale (SAS)
Self-depression scale (SDS)

Full Information

First Posted
September 30, 2014
Last Updated
November 2, 2015
Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborators
University of British Columbia, Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02594670
Brief Title
Acupuncture for Insomnia: a Randomized Controlled Trial
Acronym
AI-RCT
Official Title
Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborators
University of British Columbia, Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
acupoints, insomnia, acupuncture, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DU20 and HT7 combination
Arm Type
Experimental
Arm Description
combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7).
Arm Title
DU20 and SP6 combination
Arm Type
Other
Arm Description
combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6).
Arm Title
DU20 and SA combination
Arm Type
Sham Comparator
Arm Description
combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint.
Intervention Type
Other
Intervention Name(s)
DU20 and HT7 combination
Intervention Description
acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
Intervention Type
Other
Intervention Name(s)
DU20 and SP6 combination
Intervention Description
acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
Intervention Type
Other
Intervention Name(s)
DU20 and SA combination
Intervention Description
Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index (PSQI)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Athens Insomnia Scale (AIS)
Time Frame
4 weeks and 8 weeks
Title
Short Form 36-item Health Survey(SF-36)
Time Frame
4 weeks and 8 weeks
Title
Self-anxiety scale (SAS)
Time Frame
4 weeks and 8 weeks
Title
Self-depression scale (SDS)
Time Frame
4 weeks and 8 weeks
Other Pre-specified Outcome Measures:
Title
safety evaluation will summarize the incidence of adverse events，including itching and redness of local acupoints.
Time Frame
4 weeks
Title
adherence of acupuncture
Description
adherence to the treatment (adherence rate)will be calculated using formula: Adherence Rate = Number of Treatment Conducted/ Number of Treatment Planned
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association PSQI score >7 AIS score ≥6 SDS ≤60 SAS ≤60 Age between 18 and 65 years old Not involved in other clinical trial in the lasted 6 months before screening Have the ability to write the informed consent. Exclusion Criteria: Breathing-related sleep disorders Circadian rhythm sleep-wake disorders Medication-induced sleep disorder Substance induced sleep disorders,such as alcohol, coffee, strong tea Secondary insomnia caused by systemic diseases or caused by external environment disturbance Pregnant or lactating women Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases Advanced malignant tumor or other serious debilitating diseases Location of acupoints combined with infection and bleeding Declined to acupuncture Couldn't provide the written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang
Email
48770045@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zenghui Yue
Organizational Affiliation
Hunan University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Second Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
First Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
Hengyang hospital of Hunan University of Chinese Medicine
City
Hengyang
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zenghui Yue
Email
624755064@qq.com

12. IPD Sharing Statement

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Acupuncture for Insomnia: a Randomized Controlled Trial

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