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A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405427
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Procedure: head acupoints acupuncture Procedure: body acupoints acupuncture Not Applicable

Detailed Description:

The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: head acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the head
Procedure: 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.

Active Comparator: body acupoints acupuncture
Acupuncture treatment for 12 acupoints on both sides of the body
Procedure: 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.




Primary Outcome Measures :
  1. Changes of The Epworth sleepiness scale (ESS) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]
    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.

  2. Changes of The HADS(The Hospital Anxiety and Depression Scale) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]
    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.

  3. Changes of The PSQI(Pittsburgh Sleep Quality Index) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]
    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.


Secondary Outcome Measures :
  1. HRV(Heart rate viability) [ 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, an average of 1 year. ]
    Frequency-domain analysis of heart rate variability (HRV), a noninvasive method, has been used to reflect cardiac autonomic nervous activity in humans. The high-frequency power (HF; 0.15-0.4 Hz) of HRV represents vagal (parasympathetic) control of heart rate. The low-frequency power (LF; 0.04- 0.15 Hz) of HRV is jointly contributed by both sympathetic and vagal nerves, whereas normalized LF (nLF) is regarded as the sympathetic modulation.

  2. actigraphy (3-day) [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]
    Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time)

  3. sleep diary [ Time Frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6) ]
    The sleep diary provides daily subjective estimates of sleep parameters including: daytime nap, sleep aids intake, bedtime, sleep onset latency, frequency of nocturnal awakenings, awakenings duration, wake-up time, arising time, feeling upon arising (five-point scale) and sleep quality (five-point scale).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 20~70 years,
  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:

  1. a pregnant or lactating woman
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405427


Contacts
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Contact: Lee Tsai-Jean, MD +886-933-750-627 cs8336@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Keelung, Taiwan
Contact: Tsai-Jean LEE, MD    0978839269    Lee269@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Lee Tsai-Jean, MD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04405427    
Other Study ID Numbers: 201900496A3
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
acupuncture
primary insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders