A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia
NCT ID: NCT04405427
Last Updated: 2020-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-08-07
2021-08-31
Brief Summary
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Detailed Description
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The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.
The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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head acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the head
head acupoints acupuncture
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.
body acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the body
body acupoints acupuncture
The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
Interventions
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head acupoints acupuncture
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.
body acupoints acupuncture
The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
3. experienced insomnia at least three times a week for more than a month
4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.
Exclusion Criteria
2. the patient's insomnia is caused by mental disorders other than mild anxiety,
3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
6. the patient with cardiac pacemaker
7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
8. the patient has a history of sleep apnea
20 Years
70 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Lee Tsai-Jean, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Keelung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201900496A3
Identifier Type: -
Identifier Source: org_study_id
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