NCT02594670

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.

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
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

September 30, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

September 30, 2014

Last Update Submit

November 2, 2015

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

acupointsinsomniaacupuncturerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh sleep quality index (PSQI)

    4 weeks

Secondary Outcomes (4)

  • Athens Insomnia Scale (AIS)

    4 weeks and 8 weeks

  • Short Form 36-item Health Survey(SF-36)

    4 weeks and 8 weeks

  • Self-anxiety scale (SAS)

    4 weeks and 8 weeks

  • Self-depression scale (SDS)

    4 weeks and 8 weeks

Other Outcomes (2)

  • safety evaluation will summarize the incidence of adverse events，including itching and redness of local acupoints.

    4 weeks

  • adherence of acupuncture

    4 weeks

Study Arms (3)

DU20 and HT7 combination

EXPERIMENTAL

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

Other: DU20 and HT7 combination

DU20 and SP6 combination

OTHER

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

Other: DU20 and SP6 combination

DU20 and SA combination

SHAM COMPARATOR

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

Other: DU20 and SA combination

Interventions

DU20 and HT7 combinationOTHER

acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.

DU20 and HT7 combination
DU20 and SP6 combinationOTHER

acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.

DU20 and SP6 combination
DU20 and SA combinationOTHER

Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.

DU20 and SA combination

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Second Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410005, China

Location

First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410007, China

Location

Hengyang hospital of Hunan University of Chinese Medicine

Hengyang, Hunan, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Zenghui Yue

    Hunan University of Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Yan Wang

CONTACT

48770045@qq.com

Study Design

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

Study Record Dates

First Submitted

September 30, 2014

First Posted

November 3, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

November 3, 2015

Record last verified: 2015-03

Locations

CN(3)