<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04405427</url>
  </required_header>
  <id_info>
    <org_study_id>201900496A3</org_study_id>
    <nct_id>NCT04405427</nct_id>
  </id_info>
  <brief_title>A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia</brief_title>
  <official_title>A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia: A Randomized Controlled Case Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a single-center, and randomized controlled cases study. A&#xD;
      total of 120 participants with insomnia will be enrolled. The aim of the study is to compare&#xD;
      the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on&#xD;
      Insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a single-center, and randomized controlled cases study. A&#xD;
      total of 120 participants with insomnia will be enrolled, and randomly assigned into two&#xD;
      groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1,&#xD;
      GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60&#xD;
      of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6,&#xD;
      ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.&#xD;
&#xD;
      The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep&#xD;
      Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression&#xD;
      Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week&#xD;
      4 and week 6.&#xD;
&#xD;
      The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep&#xD;
      efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy&#xD;
      (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate&#xD;
      viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week&#xD;
      3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study&#xD;
      completion).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of The Epworth sleepiness scale (ESS)</measure>
    <time_frame>Baseline week 0, week 2, week 4 &amp; 2 weeks post-tx (week 6)</time_frame>
    <description>The Epworth sleepiness scale (ESS) containing eight items that ask for self-reported disclosure of the expectation of &quot;dozing&quot; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of The HADS(The Hospital Anxiety and Depression Scale)</measure>
    <time_frame>Baseline week 0, week 2, week 4 &amp; 2 weeks post-tx (week 6)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of The PSQI(Pittsburgh Sleep Quality Index)</measure>
    <time_frame>Baseline week 0, week 2, week 4 &amp; 2 weeks post-tx (week 6)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HRV(Heart rate viability)</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>actigraphy (3-day)</measure>
    <time_frame>Baseline week 0, week 2, week 4 &amp; 2 weeks post-tx (week 6)</time_frame>
    <description>Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep diary</measure>
    <time_frame>Baseline week 0, week 2, week 4 &amp; 2 weeks post-tx (week 6)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>head acupoints acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture treatment for 12 acupoints on both sides of the head</description>
  </arm_group>
  <arm_group>
    <arm_group_label>body acupoints acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acupuncture treatment for 12 acupoints on both sides of the body</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>head acupoints acupuncture</intervention_name>
    <description>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.</description>
    <arm_group_label>head acupoints acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>body acupoints acupuncture</intervention_name>
    <description>The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.</description>
    <arm_group_label>body acupoints acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 20~70 years,&#xD;
&#xD;
          2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders (Fifth Edition, DSM-V)&#xD;
&#xD;
          3. experienced insomnia at least three times a week for more than a month&#xD;
&#xD;
          4. voluntarily agreed with the investigation and signed a written informed con- sent form&#xD;
             before the clinical trial started.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a pregnant or lactating woman&#xD;
&#xD;
          2. the patient's insomnia is caused by mental disorders other than mild anxiety,&#xD;
&#xD;
          3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease&#xD;
&#xD;
          4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's&#xD;
             Disease)&#xD;
&#xD;
          5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before&#xD;
             the trial&#xD;
&#xD;
          6. the patient with cardiac pacemaker&#xD;
&#xD;
          7. the patient does not want to wear portable physiological signal recording device&#xD;
             (SOMNOwatchTM) and handheld ECG monitor&#xD;
&#xD;
          8. the patient has a history of sleep apnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Tsai-Jean, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lee Tsai-Jean, MD</last_name>
    <phone>+886-933-750-627</phone>
    <email>cs8336@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsai-Jean LEE, MD</last_name>
      <phone>0978839269</phone>
      <email>Lee269@cgmh.org.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>primary insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There will be a research number representing the identity. This number will not display the name, identification number, and address.&#xD;
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.&#xD;
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.&#xD;
These people also promise not to violate the confidentiality of your identity.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405427
org study id: 201900496A3
nct id: NCT04405427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Changes of The Epworth sleepiness scale (ESS)
time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
description: 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.
measure: 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)
description: 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.
measure: Changes of The PSQI(Pittsburgh Sleep Quality Index)
time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
description: 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.
measure: 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.
description: 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.
measure: actigraphy (3-day)
time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
description: Actigraphy provides objective estimates of sleep parameters including: SE(sleep efficiency), SA(sleep awakenings), TST(total sleep time)
measure: sleep diary
time frame: Baseline week 0, week 2, week 4 & 2 weeks post-tx (week 6)
description: 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).
arm group label: head acupoints acupuncture
arm group type: Experimental
description: Acupuncture treatment for 12 acupoints on both sides of the head
arm group label: body acupoints acupuncture
arm group type: Active Comparator
description: Acupuncture treatment for 12 acupoints on both sides of the body
intervention type: Procedure
intervention name: head acupoints acupuncture
description: 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.
arm group label: head acupoints acupuncture
intervention type: Procedure
intervention name: body acupoints acupuncture
description: The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
arm group label: body acupoints acupuncture
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lee Tsai-Jean, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Lee Tsai-Jean, MD
phone: +886-933-750-627
email: cs8336@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No
ipd 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.