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/NCT05985512</url>
    </required_header>
    <id_info>
      <org_study_id>ChengmeiYUAN</org_study_id>
      <nct_id>NCT05985512</nct_id>
    </id_info>
    <brief_title>Subtyping of Insomnia Disorders Based on Multidimensional Features</brief_title>
    <official_title>A Research on the Typing of Insomnia Disorder Based on Multidimensional Features</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Mental Health Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Mental Health Center</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>
        Based on real world and focusing on patients with chronic sleep disorders, this study&#xD;
        conducts a data-driven subtyping research on the clinical symptoms, polysomnography,&#xD;
        near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia&#xD;
        disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis&#xD;
        for personalized interventions for chronic insomnia disorder.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>polysomnography</measure>
      <time_frame>the end of the eighth week</time_frame>
      <description>change in total sleep time recorded by polysomnography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PSQI</measure>
      <time_frame>the end of the 24th, 36th, 48th week</time_frame>
      <description>change in total sleep time according to PSQI scale</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Insomnia Disorder</condition>
    <arm_group>
      <arm_group_label>Insomnia Disorder</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients with insomnia disorder</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
      <description>Cognitive Behavioral Therapy for Insomnia is the main therapy for the patients. Medications include sedative-hypnotics and antidepressants with a sedative effect.</description>
      <arm_group_label>Insomnia Disorder</arm_group_label>
      <other_name>Pharmalogical Therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged between 18 and 65 years, regardless of gender;&#xD;
  &#xD;
            2. Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth&#xD;
               Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);&#xD;
  &#xD;
            3. Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;&#xD;
  &#xD;
            4. Sufficient level of education and comprehension to complete the required examinations&#xD;
               and assessments for this study;&#xD;
  &#xD;
            5. Voluntarily participating in this research and signing the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Currently diagnosed with other sleep disorders (sleep-related breathing disorders,&#xD;
               periodic limb movement disorder, parasomnias, central disorders of hypersomnolence,&#xD;
               circadian rhythm sleep-wake disorders, etc.);&#xD;
  &#xD;
            2. Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease,&#xD;
               etc.) or other organic diseases;&#xD;
  &#xD;
            3. Patients with a history of or currently diagnosed with bipolar and related disorders,&#xD;
               obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic&#xD;
               disorders, trauma and stressor-related disorders, dissociative disorders, or eating&#xD;
               disorders;&#xD;
  &#xD;
            4. Women who are pregnant, breastfeeding, or planning to become pregnant during the study&#xD;
               period;&#xD;
  &#xD;
            5. Insomnia caused by alcohol or substance abuse;&#xD;
  &#xD;
            6. High suicide risk, with HAMD-17 suicide factor score &gt; 2;&#xD;
  &#xD;
            7. Inability to cooperate with near-infrared examinations and polysomnography due to&#xD;
               physical conditions such as head injury, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chengmei YUAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Mental Health Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dongbin LYU</last_name>
      <phone>86-18516743620</phone>
      <email>shuiysuper@foxmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Mental Health Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chengmei Yuan</last_name>
        <phone>86-13818132592</phone>
        <email>yuanchengmei@yeah.net</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05985512
  org study id: ChengmeiYUAN
  nct id: NCT05985512
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Based on real world and focusing on patients with chronic sleep disorders, this study
        conducts a data-driven subtyping research on the clinical symptoms, polysomnography,
        near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia
        disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis
        for personalized interventions for chronic insomnia disorder.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: polysomnography
  time frame: the end of the eighth week
  description: change in total sleep time recorded by polysomnography
  measure: PSQI
  time frame: the end of the 24th, 36th, 48th week
  description: change in total sleep time according to PSQI scale
  arm group label: Insomnia Disorder
  arm group type: Other
  description: Patients with insomnia disorder
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Therapy for Insomnia
  description: Cognitive Behavioral Therapy for Insomnia is the main therapy for the patients. Medications include sedative-hypnotics and antidepressants with a sedative effect.
  arm group label: Insomnia Disorder
  other name: Pharmalogical Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Chengmei YUAN
  role: Principal Investigator
  affiliation: Shanghai Mental Health Center
  last name: Dongbin LYU
  phone: 86-18516743620
  email: shuiysuper@foxmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No