<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/NCT02263859</url>
  </required_header>
  <id_info>
    <org_study_id>IMT 2014-01</org_study_id>
    <nct_id>NCT02263859</nct_id>
  </id_info>
  <brief_title>Targeted Hypoglossal Neurostimulation Study #3</brief_title>
  <acronym>THN3</acronym>
  <official_title>ImThera Medical Targeted Hypoglossal Neurostimulation Study #3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImThera Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>LivaNova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve&#xD;
      stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for&#xD;
      individuals with moderate to severe OSA that have failed or do not tolerate PAP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to evaluate the safety and effectiveness of the aura6000&#xD;
      System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals&#xD;
      who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or&#xD;
      are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances,&#xD;
      positional devices and conventional sleep surgeries). PAP failure is defined as an inability&#xD;
      to eliminate OSA (AHI &gt; 20 despite PAP usage) and PAP intolerance is defined as: 1) inability&#xD;
      to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of&#xD;
      use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system&#xD;
      after attempting to use it). The results of this study are anticipated to provide reasonable&#xD;
      assurance of the safety and effectiveness of the aura6000 System when used as intended and to&#xD;
      support the application for FDA Premarket Approval of the system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">June 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Apnea Hypopnea Index (AHI)</measure>
    <time_frame>Baseline to 4 months post-implant</time_frame>
    <description>Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition.&#xD;
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Oxygen Desaturation Index (ODI)</measure>
    <time_frame>Baseline to 4 months post-implant</time_frame>
    <description>Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition.&#xD;
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Analysis</measure>
    <time_frame>Baseline to 12 months post-implant</time_frame>
    <description>Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long-term Responder Rate</measure>
    <time_frame>Baseline to 12 months post-implant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>Baseline to 4 months post-implant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Outcomes of Sleep (FOSQ)</measure>
    <time_frame>Baseline to 4 months post-implant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EuroQol 5 Dimensional (EQ-5D)</measure>
    <time_frame>Baseline to 4 months post-implant</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>aura6000 System</intervention_name>
    <description>The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>THN Therapy</other_name>
    <other_name>ImThera Medical</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Individual has failed or does not tolerate PAP therapy&#xD;
&#xD;
          -  Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and&#xD;
             behavioral treatments)&#xD;
&#xD;
          -  AHI ≥ 20 (Moderate to severe OSA)&#xD;
&#xD;
        Exclusion Critera:&#xD;
&#xD;
          -  Implanted with another active implantable device&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 35 kg/m²&#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>Alan R Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor (ret.), Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ENT Associates of San Diego</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower ENT</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SENTA Clinic</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ear, Nose, and Throat Associates of South Florida</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Mease Healthcare</name>
      <address>
        <city>Safety Harbor</city>
        <state>Florida</state>
        <zip>34695</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced ENT Asociates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for ENT and Allergy</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Research Group</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intrepid Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Methodist Physicians</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Univ. Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foch Hospital</name>
      <address>
        <city>Suresnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruprechts-Karls University</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Porto</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Portugal</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive Sleep Apnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02263859
org study id: IMT 2014-01
nct id: NCT02263859
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve
      stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for
      individuals with moderate to severe OSA that have failed or do not tolerate PAP.
The objectives of this study are to evaluate the safety and effectiveness of the aura6000
      System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals
      who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or
      are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances,
      positional devices and conventional sleep surgeries). PAP failure is defined as an inability
      to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability
      to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of
      use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system
      after attempting to use it). The results of this study are anticipated to provide reasonable
      assurance of the safety and effectiveness of the aura6000 System when used as intended and to
      support the application for FDA Premarket Approval of the system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Apnea Hypopnea Index (AHI)
time frame: Baseline to 4 months post-implant
description: Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition.
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.
measure: Improvement in Oxygen Desaturation Index (ODI)
time frame: Baseline to 4 months post-implant
description: Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition.
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.
measure: Safety Analysis
time frame: Baseline to 12 months post-implant
description: Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.
measure: Long-term Responder Rate
time frame: Baseline to 12 months post-implant
measure: Change in Epworth Sleepiness Scale (ESS)
time frame: Baseline to 4 months post-implant
measure: Change in Functional Outcomes of Sleep (FOSQ)
time frame: Baseline to 4 months post-implant
measure: Change in EuroQol 5 Dimensional (EQ-5D)
time frame: Baseline to 4 months post-implant
arm group label: Treatment
arm group type: Experimental
description: The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
arm group label: Control
arm group type: Other
description: The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.
intervention type: Device
intervention name: aura6000 System
description: The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
arm group label: Control
arm group label: Treatment
other name: THN Therapy
other name: ImThera Medical
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan R Schwartz, MD
role: Principal Investigator
affiliation: Professor (ret.), Johns Hopkins University
facility: 
facility: 
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country: Belgium
country: France
country: Germany
country: Israel
country: Portugal
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive