<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/NCT04507646</url>
  </required_header>
  <id_info>
    <org_study_id>N202001048</org_study_id>
    <nct_id>NCT04507646</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population</brief_title>
  <official_title>The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</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 study aims to examine the effect of auricular acupuncture on improving oral health in&#xD;
      older population. The hypothesis of this study is that older people receiving auricular&#xD;
      acupuncture can increase salivary secretion. By identifying the effectiveness of auricular&#xD;
      acupuncture can increase salivary secretion; suitable care can be suggested to improve oral&#xD;
      health in older population living in long-term institutions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The elderly living in long-term institutions are mostly limited to physical dysfunction and&#xD;
      highly dependence. In addition, the chronic diseases are affected by taking a variety of&#xD;
      drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion&#xD;
      of saliva is high recommended to those older population. The study is used to examine the&#xD;
      effect of auricular acupuncture on improving oral health in older population. The eligible&#xD;
      participants are random assign to experimental group receiving auricular acupuncture and&#xD;
      control group having ineffective auricular acupuncture. Outcome measures include demographic&#xD;
      variables, general health status and secretion of saliva, such as: Subjective dry mouth&#xD;
      condition and objective mouth condition. Generalized linear model will be used to examine the&#xD;
      effect of auricular acupuncture on improving oral health. By identifying the effectiveness of&#xD;
      auricular acupuncture can increase salivary secretion; suitable care can be suggested to&#xD;
      improve oral health in older population living in long-term institutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 2, 2020</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Two blinded researchers indenpendent performered auricular acupuncture for experimental or control group, respectively.&#xD;
Experimental group receive true auricular acupuncture and control group receive sham auricular acupuncture.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective dry mouth health</measure>
    <time_frame>pre-test and post-test</time_frame>
    <description>self-rated salivation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective dry mouth health</measure>
    <time_frame>pre-test and post-test</time_frame>
    <description>Salivation measured by Oral moisture meter</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Salivary Gland Diseases</condition>
  <arm_group>
    <arm_group_label>True auricular acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effective auricular acupuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham auricular acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Ineffective auricular acupuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>True auricular acupuncture</intervention_name>
    <description>The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.</description>
    <arm_group_label>True auricular acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham auricular acupuncture</intervention_name>
    <description>The participant in control group will receive acupuncture on ineffective point at ear.</description>
    <arm_group_label>Sham auricular acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Residents in long-term institutions aged over 65 years old&#xD;
&#xD;
          2. Living in long-term institutions at least six months and above&#xD;
&#xD;
          3. Having normal cognitive functions with Mini-Mental State Examination scores more than&#xD;
             25 scores.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The resident whose acupuncture point has Trauma, eczema or ulcer.&#xD;
&#xD;
          2. Incapable of salivary secretion caused by disease,sush as radiation-induced xerostomia&#xD;
             among patients with nasopharyngeal carcinoma, Sjogren's Syndrome,acute&#xD;
             sialadenitis,chronic recurrent sialadenitis,viral salivary gland infection,salivary&#xD;
             gland stones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui-Chuan Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yilan Yuanshan Hopsital</name>
      <address>
        <city>Yilan City</city>
        <zip>26443</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Huang, Hui-Chuan</investigator_full_name>
    <investigator_title>The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salivary Gland Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04507646
org study id: N202001048
nct id: NCT04507646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to examine the effect of auricular acupuncture on improving oral health in
      older population. The hypothesis of this study is that older people receiving auricular
      acupuncture can increase salivary secretion. By identifying the effectiveness of auricular
      acupuncture can increase salivary secretion; suitable care can be suggested to improve oral
      health in older population living in long-term institutions.
The elderly living in long-term institutions are mostly limited to physical dysfunction and
      highly dependence. In addition, the chronic diseases are affected by taking a variety of
      drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion
      of saliva is high recommended to those older population. The study is used to examine the
      effect of auricular acupuncture on improving oral health in older population. The eligible
      participants are random assign to experimental group receiving auricular acupuncture and
      control group having ineffective auricular acupuncture. Outcome measures include demographic
      variables, general health status and secretion of saliva, such as: Subjective dry mouth
      condition and objective mouth condition. Generalized linear model will be used to examine the
      effect of auricular acupuncture on improving oral health. By identifying the effectiveness of
      auricular acupuncture can increase salivary secretion; suitable care can be suggested to
      improve oral health in older population living in long-term institutions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Two blinded researchers indenpendent performered auricular acupuncture for experimental or control group, respectively.
Experimental group receive true auricular acupuncture and control group receive sham auricular acupuncture.
measure: Subjective dry mouth health
time frame: pre-test and post-test
description: self-rated salivation
measure: Objective dry mouth health
time frame: pre-test and post-test
description: Salivation measured by Oral moisture meter
arm group label: True auricular acupuncture
arm group type: Experimental
description: Effective auricular acupuncture
arm group label: Sham auricular acupuncture
arm group type: Sham Comparator
description: Ineffective auricular acupuncture
intervention type: Other
intervention name: True auricular acupuncture
description: The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
arm group label: True auricular acupuncture
intervention type: Other
intervention name: sham auricular acupuncture
description: The participant in control group will receive acupuncture on ineffective point at ear.
arm group label: Sham auricular acupuncture
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hui-Chuan Huang, PhD
role: Principal Investigator
affiliation: Taipei Medical University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Huang, Hui-Chuan
investigator title: The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population
mesh term: Salivary Gland Diseases