<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/NCT03015766</url>
  </required_header>
  <id_info>
    <org_study_id>YN2015MS25</org_study_id>
    <nct_id>NCT03015766</nct_id>
  </id_info>
  <brief_title>Auricular Acupressure for Hemodialysis Patients With Insomnia</brief_title>
  <acronym>AAHDIN</acronym>
  <official_title>Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</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>
      Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent&#xD;
      years and yielded favorable results. However, the effect and safety of AAT for insomnia in&#xD;
      MHD population still lacks high quality evidence. A randomized controlled clinical trial is&#xD;
      planned to evaluate the effect and safety of AAT in MHD patients with insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insomnia, a worldwide health problem, is much more frequently complained in maintenance&#xD;
      hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic&#xD;
      sedative agents are often reluctantly prescribed with doses mounting up. Patients are&#xD;
      concerned about drug dependence and drug-related adverse effects. As a non-drug therapy,&#xD;
      auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is&#xD;
      widely used to treat many conditions in China. The investigators had been applying AAT for&#xD;
      MHD patients with insomnia in recent years and yielded favorable results. However, the effect&#xD;
      and safety of AAT for insomnia in MHD population still lacks high quality evidence.&#xD;
      Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD&#xD;
      patients with insomnia to evaluate the effect and safety of AAT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical response rate</measure>
    <time_frame>at 8 weeks from baseline</time_frame>
    <description>Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of PSQI scores at the end of treatment</measure>
    <time_frame>change from baseline PSQI scores at 8 weeks</time_frame>
    <description>PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of PSQI scores at the first followup</measure>
    <time_frame>change from baseline PSQI scores at 12 weeks</time_frame>
    <description>PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of PSQI scores at the second followup</measure>
    <time_frame>change from baseline PSQI scores at 16 weeks</time_frame>
    <description>PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of PSQI scores at the third followup</measure>
    <time_frame>change from baseline PSQI scores at 20 weeks</time_frame>
    <description>PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weekly dose of hypnotics</measure>
    <time_frame>Day 0 (baseline), at 8 weeks (the end of treatment), at 12 weeks (the first followup),at 16 weeks (the second followup) and at 20 weeks (the third followup)</time_frame>
    <description>If participants required hypnotic agents during the study because of unbearable sleep disorders, they will be allowed to take hypnotics initiating from the minimum dose and encouraged to complete the trial. The weekly dose of hypnotic agents will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>through study completion, an average of 20 weeks</time_frame>
    <description>Adverse events throughout the treatment and follow-up periods, regardless of its relevance to the interventions, will be documented and dealt with by appropriate measures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Insomnia Chronic</condition>
  <arm_group>
    <arm_group_label>Auricular acupressure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham auricular acupressure therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>auricular acupressure therapy</intervention_name>
    <description>Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.</description>
    <arm_group_label>Auricular acupressure therapy</arm_group_label>
    <other_name>auricular acupressure</other_name>
    <other_name>ear acupressure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham auricular acupressure therapy</intervention_name>
    <description>The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.</description>
    <arm_group_label>sham auricular acupressure therapy</arm_group_label>
    <other_name>sham AAT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18~75 years&#xD;
&#xD;
          -  On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly&#xD;
             dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)&#xD;
&#xD;
          -  Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth&#xD;
             Edition (DSM-5)&#xD;
&#xD;
          -  Global score of PSQI &gt; 7&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of co-morbidities including cancer, congestive heart failure, connective&#xD;
             tissue disease and hematologic diseases;&#xD;
&#xD;
          -  Inadequately dialyzed, indicating by urea clearance index (KT/V) &lt; 1.20;&#xD;
&#xD;
          -  Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and&#xD;
             restless legs which are obviously causative for insomnia; and weary condition caused&#xD;
             by severe anemia (hemoglobin&lt;60g/L) or malnutrition (serum albumin&lt;30g/L).&#xD;
&#xD;
          -  Infections of external ears or malformed ears.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qizhan Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou HEMC (Higher Education Mega Center) Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510130</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Charity Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510370</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuyi Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Jiangsu Sheng</city>
        <state>Guangdong</state>
        <zip>529099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shebu</city>
        <state>Guangdong</state>
        <zip>518026</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122724</url>
    <description>previously finished pilot RCT</description>
  </link>
  <link>
    <url>http://online.liebertpub.com/doi/abs/10.1089/acm.2013.0319</url>
    <description>observational study on auricular acupressure</description>
  </link>
  <results_reference>
    <citation>Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.</citation>
    <PMID>25874938</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu Y, Zou C, Liu X, Wu X, Lin Q. Auricular acupressure helps improve sleep quality for severe insomnia in maintenance hemodialysis patients: a pilot study. J Altern Complement Med. 2014 May;20(5):356-63. doi: 10.1089/acm.2013.0319. Epub 2014 Feb 26.</citation>
    <PMID>24571603</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Qizhan Lin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>insomnia</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>auricular acupressure</keyword>
  <keyword>randomized controlled trial</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>Yes</sharing_ipd>
    <ipd_description>IPD including the demographic information, PSQI scores and drug use at baseline and 8,12,16,20 week from baseline of all participants will be shared. The data will be availbale at ResMan® Clinical Trial Management Public Platform, with the link http://www.medresman.org/uc/index.aspx</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/NCT03015766
org study id: YN2015MS25
nct id: NCT03015766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent
      years and yielded favorable results. However, the effect and safety of AAT for insomnia in
      MHD population still lacks high quality evidence. A randomized controlled clinical trial is
      planned to evaluate the effect and safety of AAT in MHD patients with insomnia.
Insomnia, a worldwide health problem, is much more frequently complained in maintenance
      hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic
      sedative agents are often reluctantly prescribed with doses mounting up. Patients are
      concerned about drug dependence and drug-related adverse effects. As a non-drug therapy,
      auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is
      widely used to treat many conditions in China. The investigators had been applying AAT for
      MHD patients with insomnia in recent years and yielded favorable results. However, the effect
      and safety of AAT for insomnia in MHD population still lacks high quality evidence.
      Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD
      patients with insomnia to evaluate the effect and safety of AAT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: clinical response rate
time frame: at 8 weeks from baseline
description: Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review
measure: change of PSQI scores at the end of treatment
time frame: change from baseline PSQI scores at 8 weeks
description: PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
measure: change of PSQI scores at the first followup
time frame: change from baseline PSQI scores at 12 weeks
description: PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
measure: change of PSQI scores at the second followup
time frame: change from baseline PSQI scores at 16 weeks
description: PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
measure: change of PSQI scores at the third followup
time frame: change from baseline PSQI scores at 20 weeks
description: PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
measure: weekly dose of hypnotics
time frame: Day 0 (baseline), at 8 weeks (the end of treatment), at 12 weeks (the first followup),at 16 weeks (the second followup) and at 20 weeks (the third followup)
description: If participants required hypnotic agents during the study because of unbearable sleep disorders, they will be allowed to take hypnotics initiating from the minimum dose and encouraged to complete the trial. The weekly dose of hypnotic agents will be recorded.
measure: adverse events
time frame: through study completion, an average of 20 weeks
description: Adverse events throughout the treatment and follow-up periods, regardless of its relevance to the interventions, will be documented and dealt with by appropriate measures.
arm group label: Auricular acupressure therapy
arm group type: Experimental
description: Participants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18)
arm group label: sham auricular acupressure therapy
arm group type: Sham Comparator
description: Participants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management.
intervention type: Other
intervention name: auricular acupressure therapy
description: Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.
arm group label: Auricular acupressure therapy
other name: auricular acupressure
other name: ear acupressure
intervention type: Other
intervention name: sham auricular acupressure therapy
description: The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.
arm group label: sham auricular acupressure therapy
other name: sham AAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qizhan Lin, MD
role: Principal Investigator
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122724
description: previously finished pilot RCT
url: http://online.liebertpub.com/doi/abs/10.1089/acm.2013.0319
description: observational study on auricular acupressure
citation: Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.
PMID: 25874938
citation: Wu Y, Zou C, Liu X, Wu X, Lin Q. Auricular acupressure helps improve sleep quality for severe insomnia in maintenance hemodialysis patients: a pilot study. J Altern Complement Med. 2014 May;20(5):356-63. doi: 10.1089/acm.2013.0319. Epub 2014 Feb 26.
PMID: 24571603
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Qizhan Lin
investigator title: Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Yes
ipd description: IPD including the demographic information, PSQI scores and drug use at baseline and 8,12,16,20 week from baseline of all participants will be shared. The data will be availbale at ResMan® Clinical Trial Management Public Platform, with the link http://www.medresman.org/uc/index.aspx