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/NCT06021795</url>
    </required_header>
    <id_info>
      <org_study_id>CP-006</org_study_id>
      <nct_id>NCT06021795</nct_id>
    </id_info>
    <brief_title>Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia</brief_title>
    <official_title>Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Third Wave Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Third Wave Therapeutics</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Assess the effect of a customized audio track delivered via standard commercially-available&#xD;
        bone conduction headsets on the quality of sleep&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A single-center study in 25 subjects suffering from moderate to severe insomnia and assess&#xD;
        the effectiveness of the intervention. Intervention consists of treatment using a customized&#xD;
        audio track delivered via standard commercially-available bone conduction headsets daily for&#xD;
        four (4) weeks. Effectiveness is defined by a statistically significant improvement in&#xD;
        Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus&#xD;
        the end of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Effectiveness</measure>
      <time_frame>4 weeks</time_frame>
      <description>Reduction in Insomnia Severity Index (ISI)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Effectiveness</measure>
      <time_frame>4 weeks</time_frame>
      <description>Reduction in Pittsburgh Sleep Quality Index (PSQI)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sound Treatment</intervention_name>
      <description>Customized sound audio track delivered via standard commercially available bone conduction headset</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
            -  Meets DSM 5 criteria for insomnia disorder&#xD;
  &#xD;
            -  Insomnia Severity Index (ISI) of 15 - 28&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of sleep medications, sedating or alerting medications or antidepressants in the&#xD;
               last 3 months&#xD;
  &#xD;
            -  Diagnosis of any autoimmune disorder or any medical or sleep disorder that could&#xD;
               affect sleep&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elan Hekier, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>San Francisco Otolaryngology Medical Group</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paramesh Gopi, PhD</last_name>
      <phone>408-316-3631</phone>
      <email>pgopi@soundhealth.life</email>
    </overall_contact>
    <location>
      <facility>
        <name>San Francisco Otolaryngology Medical Group</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elan Hekier</last_name>
        <phone>415-362-5443</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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/NCT06021795
  org study id: CP-006
  nct id: NCT06021795
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Assess the effect of a customized audio track delivered via standard commercially-available
        bone conduction headsets on the quality of sleep
  A single-center study in 25 subjects suffering from moderate to severe insomnia and assess
        the effectiveness of the intervention. Intervention consists of treatment using a customized
        audio track delivered via standard commercially-available bone conduction headsets daily for
        four (4) weeks. Effectiveness is defined by a statistically significant improvement in
        Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus
        the end of the study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Effectiveness
  time frame: 4 weeks
  description: Reduction in Insomnia Severity Index (ISI)
  measure: Secondary Effectiveness
  time frame: 4 weeks
  description: Reduction in Pittsburgh Sleep Quality Index (PSQI)
  arm group label: Intervention
  arm group type: Experimental
  description: Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets
  intervention type: Device
  intervention name: Sound Treatment
  description: Customized sound audio track delivered via standard commercially available bone conduction headset
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elan Hekier, MD
  role: Principal Investigator
  affiliation: San Francisco Otolaryngology Medical Group
  last name: Paramesh Gopi, PhD
  phone: 408-316-3631
  email: pgopi@soundhealth.life
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No