A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia
1 other identifier
interventional
120
1 country
1
Brief Summary
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
1 active site
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
May 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedAugust 25, 2020
May 1, 2020
10 months
May 24, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes of The Epworth sleepiness scale (ESS)
The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of "dozing" in a variety of situations. A sum of responses is calculated for a total score ranging from 0 to 24, higher scores mean a worse. outcome.
Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Changes of The HADS(The Hospital Anxiety and Depression Scale)
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, the scores ranged from 0 to 21 for anxiety and 0 to 21 for depression, higher scores mean a worse outcome.
Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Changes of The PSQI(Pittsburgh Sleep Quality Index)
The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Secondary Outcomes (3)
HRV(Heart rate viability)
Baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion, an average of 1 year.
actigraphy (3-day)
Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
sleep diary
Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
Study Arms (2)
head acupoints acupuncture
EXPERIMENTALAcupuncture treatment for 12 acupoints on both sides of the head
body acupoints acupuncture
ACTIVE COMPARATORAcupuncture treatment for 12 acupoints on both sides of the body
Interventions
The participants will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and GB13 head acupoints aupunture treatment 3 times/ 1 week for 4 weeks.
The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
Eligibility Criteria
You may qualify if:
- aged 20\~70 years,
- met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
- experienced insomnia at least three times a week for more than a month
- voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
You may not qualify if:
- a pregnant or lactating woman
- the patient's insomnia is caused by mental disorders other than mild anxiety,
- the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
- the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
- the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
- the patient with cardiac pacemaker
- the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
- the patient has a history of sleep apnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Keelung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lee Tsai-Jean, MD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2020
First Posted
May 28, 2020
Study Start
August 7, 2020
Primary Completion
May 31, 2021
Study Completion
August 31, 2021
Last Updated
August 25, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
There will be a research number representing the identity. This number will not display the name, identification number, and address. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.