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/NCT05981183</url>
    </required_header>
    <id_info>
      <org_study_id>23-00778</org_study_id>
      <nct_id>NCT05981183</nct_id>
    </id_info>
    <brief_title>Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population</brief_title>
    <official_title>A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NYU Langone Health</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_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this pilot interventional study is to collect preliminary data on the&#xD;
        application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients&#xD;
        with chronic kidney disease (CKD). This data will enhance understanding of the short-term&#xD;
        safety, tolerability and effects of this novel therapeutic approach in the setting of CKD.&#xD;
        The primary aims are to investigate the feasibility of the protocol and generate preliminary&#xD;
        signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The&#xD;
        pilot estimates will be used to design a larger scale study that may lead to potentially&#xD;
        targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">August 7, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2025</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heart Rate Variability (HRV) at Baseline</measure>
      <time_frame>Day 1 (15 minutes prior to administration of intervention)</time_frame>
      <description>HRV is the variation in the time interval between heartbeats.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HRV at Post-Intervention</measure>
      <time_frame>Day 1 (15 minutes Post-Intervention)</time_frame>
      <description>HRV is the variation in the time interval between heartbeats.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention</measure>
      <time_frame>Day 1 (Up to 15 Minutes Post-Intervention)</time_frame>
      <description>The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure at Baseline</measure>
      <time_frame>Day 1 (15 minutes prior to administration of intervention)</time_frame>
      <description>Blood pressure measured continuously for 15 minutes prior to intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure at Post-Intervention</measure>
      <time_frame>Day 1 (15 minutes Post-Intervention)</time_frame>
      <description>Blood pressure measured continuously for 15 minutes post-intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spontaneous Baroreceptor Sensitivity (BRS) at Baseline</measure>
      <time_frame>Day 1 (15 minutes prior to administration of intervention)</time_frame>
      <description>Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spontaneous BRS at Post-Intervention</measure>
      <time_frame>Day 1 (15 minutes Post-Intervention)</time_frame>
      <description>Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate at Baseline</measure>
      <time_frame>Day 1 (15 minutes prior to administration of intervention)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate at Post-Intervention</measure>
      <time_frame>Day 1 (15 minutes Post-Intervention)</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Chronic Kidney Disease</condition>
    <arm_group>
      <arm_group_label>Intervention A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 300 μs, frequency = 25 Hz.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous electrical nerve stimulation unit (TENS)</intervention_name>
      <description>The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.</description>
      <arm_group_label>Intervention A</arm_group_label>
      <arm_group_label>Intervention B</arm_group_label>
      <other_name>TENS Device 7000</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Individual 18-80 years of age with CKD stage 3-5 (eGFR &lt;60 mL/min/1.73m2) on most recent&#xD;
          outpatient labs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pacemaker dependent&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Pregnant women. A pregnancy test will be offered if a subject is concerned about being&#xD;
               pregnant.&#xD;
  &#xD;
            -  Not capable of informed consent&#xD;
  &#xD;
            -  Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)&#xD;
  &#xD;
            -  ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial&#xD;
               fibrillation)&#xD;
  &#xD;
            -  Recent myocardial infarction (4 weeks or less)&#xD;
  &#xD;
            -  Maintenance dialysis&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Patients on labetalol (labetalol will interfere with catecholamine measurements)&#xD;
  &#xD;
            -  Patients with diabetes&#xD;
  &#xD;
            -  At least 50% of cohort must not be on beta blockers. This will help to distinguish the&#xD;
               confounding effects of beta blockers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Charytan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David Charytan, MD</last_name>
      <phone>(646) 501-9086</phone>
      <email>David.charytan@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qandeel Soomro, MD</last_name>
      <phone>(212) 263-7300</phone>
      <email>Qandeel.soomro@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>11215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </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/NCT05981183
  org study id: 23-00778
  nct id: NCT05981183
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this pilot interventional study is to collect preliminary data on the
        application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients
        with chronic kidney disease (CKD). This data will enhance understanding of the short-term
        safety, tolerability and effects of this novel therapeutic approach in the setting of CKD.
        The primary aims are to investigate the feasibility of the protocol and generate preliminary
        signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The
        pilot estimates will be used to design a larger scale study that may lead to potentially
        targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Heart Rate Variability (HRV) at Baseline
  time frame: Day 1 (15 minutes prior to administration of intervention)
  description: HRV is the variation in the time interval between heartbeats.
  measure: HRV at Post-Intervention
  time frame: Day 1 (15 minutes Post-Intervention)
  description: HRV is the variation in the time interval between heartbeats.
  measure: Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention
  time frame: Day 1 (Up to 15 Minutes Post-Intervention)
  description: The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.
  measure: Blood Pressure at Baseline
  time frame: Day 1 (15 minutes prior to administration of intervention)
  description: Blood pressure measured continuously for 15 minutes prior to intervention.
  measure: Blood Pressure at Post-Intervention
  time frame: Day 1 (15 minutes Post-Intervention)
  description: Blood pressure measured continuously for 15 minutes post-intervention.
  measure: Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
  time frame: Day 1 (15 minutes prior to administration of intervention)
  description: Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
  measure: Spontaneous BRS at Post-Intervention
  time frame: Day 1 (15 minutes Post-Intervention)
  description: Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
  measure: Heart Rate at Baseline
  time frame: Day 1 (15 minutes prior to administration of intervention)
  measure: Heart Rate at Post-Intervention
  time frame: Day 1 (15 minutes Post-Intervention)
  arm group label: Intervention A
  arm group type: Experimental
  description: Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz.
  arm group label: Intervention B
  arm group type: Experimental
  description: Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 300 μs, frequency = 25 Hz.
  intervention type: Device
  intervention name: Transcutaneous electrical nerve stimulation unit (TENS)
  description: The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.
  arm group label: Intervention A
  arm group label: Intervention B
  other name: TENS Device 7000
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: David Charytan, MD
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: David Charytan, MD
  phone: (646) 501-9086
  email: David.charytan@nyulangone.org
  last name: Qandeel Soomro, MD
  phone: (212) 263-7300
  email: Qandeel.soomro@nyulangone.org
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.