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/NCT06038006</url>
    </required_header>
    <id_info>
      <org_study_id>20221128</org_study_id>
      <nct_id>NCT06038006</nct_id>
    </id_info>
    <brief_title>A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System</brief_title>
    <official_title>A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changsha Tsingray Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Tsingray Technology Co., Ltd.</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>
        This study compares the diagnostic capability of a millimeter-wave radar-based Sleep&#xD;
        Respiratory Monitoring System to the gold standard polysomnography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG),&#xD;
        which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the&#xD;
        comfortability of patients and accessibility of diagnosis. A novel contactless&#xD;
        millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to&#xD;
        assist sleep staging and the diagnosis of sleep breathing disorders.&#xD;
  &#xD;
        The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and&#xD;
        analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a&#xD;
        millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated&#xD;
        algorithm enables the system to detect respiratory events and estimate sleep stages based on&#xD;
        the collected data. The device and algorithms are to be validated in this study by comparison&#xD;
        with PSG.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>During this study, results of the radar-based Sleep Respiratory Monitoring System are not known by the investigator and outcomes assessor, including the personnel who scores PSG.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS in participants with AHI ≥ 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS in participants with AHI ≥ 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Specificity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) &lt; 5 events per hour according to SRMS in participants with AHI &lt; 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Specificity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) &lt; 15 events per hour according to SRMS in participants with AHI &lt; 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Specificity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)</measure>
      <time_frame>Day 1</time_frame>
      <description>The proportion of participants with Apnea Hypopnea Index (AHI) &lt; 30 events per hour according to SRMS in participants with AHI &lt; 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)</measure>
      <time_frame>Day 1</time_frame>
      <description>ICC between AHI according to Sleep Respiratory Monitoring System (SRMS) and AHI according to Polysomnography (PSG), using one-way random effects model.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)</measure>
      <time_frame>Day 1</time_frame>
      <description>ICC between TST according to Sleep Respiratory Monitoring System (SRMS) and TST according to Polysomnography (PSG), using one-way random effects model.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion</measure>
      <time_frame>Day 1</time_frame>
      <description>ICC between the proportion of deep sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N3 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion</measure>
      <time_frame>Day 1</time_frame>
      <description>ICC between the proportion of light sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N1 sleep time plus stage N2 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion</measure>
      <time_frame>Day 1</time_frame>
      <description>ICC between the proportion of REM sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage R sleep time in TST according to Polysomnography (PSG), using one-way random effects model.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Sleep Breathing Disorders</condition>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The only arm containing participants of this study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Sleep Respiratory Monitoring System</intervention_name>
      <description>Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG</description>
      <arm_group_label>Participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants is 18 years of age or older.&#xD;
  &#xD;
            -  Participants is willing to undergo overnight polysomnography and Sleep Respiratory&#xD;
               Monitoring System testing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with severe cardiovascular and cerebrovascular diseases, severe liver,&#xD;
               kidney, and lung dysfunction.&#xD;
  &#xD;
            -  Participants with unstable respiratory diseases, or other diseases in acute phase.&#xD;
  &#xD;
            -  Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs&#xD;
               that may affect sleep.&#xD;
  &#xD;
            -  Participants that undergo CPAP treatment during the night of the trial.&#xD;
  &#xD;
            -  Participants with other sleep disorders, e.g. insomnia.&#xD;
  &#xD;
            -  Participants with mental disorders.&#xD;
  &#xD;
            -  Participants that refuse to sign informed consents.&#xD;
  &#xD;
            -  Participants unable to cooperate with medical examination.&#xD;
  &#xD;
            -  Participants excluded in the opinion of the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shankai Yin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai 6th People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian Guan</last_name>
      <phone>18930172210</phone>
      <phone_ext>+86</phone_ext>
      <email>guanjian0606@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai Sixth People's Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jian Guan</last_name>
        <phone>18930172210</phone>
        <phone_ext>+86</phone_ext>
        <email>guanjian0606@sina.com</email>
      </contact>
      <investigator>
        <last_name>Shankai Yin</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Respiratory Aspiration</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/NCT06038006
  org study id: 20221128
  nct id: NCT06038006
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study compares the diagnostic capability of a millimeter-wave radar-based Sleep
        Respiratory Monitoring System to the gold standard polysomnography.
  The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG),
        which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the
        comfortability of patients and accessibility of diagnosis. A novel contactless
        millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to
        assist sleep staging and the diagnosis of sleep breathing disorders.
  
        The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and
        analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a
        millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated
        algorithm enables the system to detect respiratory events and estimate sleep stages based on
        the collected data. The device and algorithms are to be validated in this study by comparison
        with PSG.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  masking description: During this study, results of the radar-based Sleep Respiratory Monitoring System are not known by the investigator and outcomes assessor, including the personnel who scores PSG.
  measure: Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS in participants with AHI ≥ 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS in participants with AHI ≥ 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Diagnostic Specificity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) < 5 events per hour according to SRMS in participants with AHI < 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Diagnostic Specificity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) < 15 events per hour according to SRMS in participants with AHI < 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Diagnostic Specificity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
  time frame: Day 1
  description: The proportion of participants with Apnea Hypopnea Index (AHI) < 30 events per hour according to SRMS in participants with AHI < 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
  measure: Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)
  time frame: Day 1
  description: ICC between AHI according to Sleep Respiratory Monitoring System (SRMS) and AHI according to Polysomnography (PSG), using one-way random effects model.
  measure: Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)
  time frame: Day 1
  description: ICC between TST according to Sleep Respiratory Monitoring System (SRMS) and TST according to Polysomnography (PSG), using one-way random effects model.
  measure: Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion
  time frame: Day 1
  description: ICC between the proportion of deep sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N3 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
  measure: Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion
  time frame: Day 1
  description: ICC between the proportion of light sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N1 sleep time plus stage N2 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
  measure: Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion
  time frame: Day 1
  description: ICC between the proportion of REM sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage R sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
  arm group label: Participants
  arm group type: Experimental
  description: The only arm containing participants of this study.
  intervention type: Diagnostic Test
  intervention name: Sleep Respiratory Monitoring System
  description: Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG
  arm group label: Participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shankai Yin
  role: Principal Investigator
  affiliation: Shanghai 6th People's Hospital
  last name: Jian Guan
  phone: 18930172210
  phone ext: +86
  email: guanjian0606@sina.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration