xml: <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/NCT06009172</url>
    </required_header>
    <id_info>
      <org_study_id>XMYY-2022KY055-01</org_study_id>
      <nct_id>NCT06009172</nct_id>
    </id_info>
    <brief_title>APA on Sleep Quality in Women With PCOS</brief_title>
    <official_title>The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Xiamen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Xiamen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep&#xD;
        problems. The aim of this study was to explore the effect of auricular point acupressure&#xD;
        (APA) pressure on sleep quality in women with PCOS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age&#xD;
        women. In recent years, women with PCOS appear to have an increased frequency of sleep&#xD;
        problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was&#xD;
        to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women&#xD;
        with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety&#xD;
        level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So&#xD;
        as to provide a sleep management strategy in PCOS women for future clinical practice&#xD;
        guidelines.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 24, 2022</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Baseline and 30 days</time_frame>
      <description>The PSQI is a cornerstone tool for the assessment of sleep quality</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)</measure>
      <time_frame>Baseline and 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Rating Anxiety Scale (SAS)</measure>
      <time_frame>Baseline and 30 days</time_frame>
      <description>The cutoff value for anxiety assessment of Self-Rating Anxiety Scale (SAS) is 50 oints, and the higher the score, the more obvious the anxiety tendency. Below 49 is normal; 50-59 is mild; 60-69 is moderate; A score of 69 or above is considered severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Testosterone (T) level(ng/mL）</measure>
      <time_frame>Baseline and 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progesterone (P) level(ng/mL）</measure>
      <time_frame>Baseline and 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fasting serum insulin (pmol/L)</measure>
      <time_frame>Baseline and 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fasting blood-glucose(mmol/L)</measure>
      <time_frame>Baseline and 30 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">88</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>APA group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Auricular point acupressure (APA)</intervention_name>
      <description>Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks.</description>
      <arm_group_label>APA group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Subjects were included if they&#xD;
  &#xD;
            1. were aged between 18-40 years old;&#xD;
  &#xD;
            2. met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with&#xD;
               sleep disorders;&#xD;
  &#xD;
            3. were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7&#xD;
               points;&#xD;
  &#xD;
            4. did not participate in other clinical trials.&#xD;
  &#xD;
          Subjects were excluded if they&#xD;
  &#xD;
            1. had a serious organic condition such as cardiovascular, cerebrovascular, liver, or&#xD;
               kidney disease;&#xD;
  &#xD;
            2. had acute gynecological inflammation, gynecological tumors, or reproductive system&#xD;
               malformations;&#xD;
  &#xD;
            3. had severe anxiety, depression, or other mental illnesses;&#xD;
  &#xD;
            4. were pregnant;&#xD;
  &#xD;
            5. had used sleeping and sedative drugs in the past month;&#xD;
  &#xD;
            6. were allergic to ear point tape;&#xD;
  &#xD;
            7. had local rupture of the skin at the selected ear point;&#xD;
  &#xD;
            8. refused to fill out questionnaires and sign informed consent forms.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <zip>361003</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009172
  org study id: XMYY-2022KY055-01
  nct id: NCT06009172
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep
        problems. The aim of this study was to explore the effect of auricular point acupressure
        (APA) pressure on sleep quality in women with PCOS.
  Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age
        women. In recent years, women with PCOS appear to have an increased frequency of sleep
        problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was
        to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women
        with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety
        level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So
        as to provide a sleep management strategy in PCOS women for future clinical practice
        guidelines.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Baseline and 30 days
  description: The PSQI is a cornerstone tool for the assessment of sleep quality
  measure: Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
  time frame: Baseline and 30 days
  measure: Self-Rating Anxiety Scale (SAS)
  time frame: Baseline and 30 days
  description: The cutoff value for anxiety assessment of Self-Rating Anxiety Scale (SAS) is 50 oints, and the higher the score, the more obvious the anxiety tendency. Below 49 is normal; 50-59 is mild; 60-69 is moderate; A score of 69 or above is considered severe.
  measure: Testosterone (T) level(ng/mL）
  time frame: Baseline and 30 days
  measure: Progesterone (P) level(ng/mL）
  time frame: Baseline and 30 days
  measure: fasting serum insulin (pmol/L)
  time frame: Baseline and 30 days
  measure: fasting blood-glucose(mmol/L)
  time frame: Baseline and 30 days
  arm group label: APA group
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Other
  intervention name: Auricular point acupressure (APA)
  description: Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks.
  arm group label: APA group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Polycystic Ovary Syndrome
  mesh term: Syndrome