<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/NCT04457154</url>
  </required_header>
  <id_info>
    <org_study_id>2020-002</org_study_id>
    <nct_id>NCT04457154</nct_id>
  </id_info>
  <brief_title>Pediatric Post-Approval Registry</brief_title>
  <official_title>Inspire Pediatric Post-Approval Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inspire Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inspire Medical Systems, Inc.</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_ppsd>Yes</is_ppsd>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages&#xD;
      18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System&#xD;
      for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects&#xD;
      will be followed for 5 years post-implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages&#xD;
      18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System&#xD;
      for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects&#xD;
      will be followed for 5 years post-implant.&#xD;
&#xD;
      Subjects will be recruited in accordance with the approved Inspire UAS indication for use and&#xD;
      will only include those subjects who are within the new age indication (18-21 years of age).&#xD;
      Implanted subjects must meet the registry eligibility criteria. Those subjects that are&#xD;
      enrolled but fail to meet the eligibility criteria will be considered screen failures.&#xD;
&#xD;
      This registry will collect safety and effectiveness data on 60 implanted subjects at a&#xD;
      minimum of 5 qualified clinical centers in the United States.&#xD;
&#xD;
      Study data will be collected at the following timepoints:&#xD;
&#xD;
      Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant&#xD;
&#xD;
      1, 2, 3, 4, 5 years post-implant&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2021</start_date>
  <completion_date type="Anticipated">April 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Evaluation of device and/or procedure related adverse events over time</measure>
    <time_frame>Implant through 5 years post-implant</time_frame>
    <description>relevant adverse events will be collected and reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time</measure>
    <time_frame>through 5 years post-implant</time_frame>
    <description>Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of improvement in Oxygen Desaturation Index (ODI) over time</measure>
    <time_frame>through 5 years post-implant</time_frame>
    <description>Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) &lt; 90%) over time</measure>
    <time_frame>through 5 years post-implant</time_frame>
    <description>Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) &lt; 90%. A lower T90 indicates less severe sleep apnea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time</measure>
    <time_frame>through 5 years post-implant</time_frame>
    <description>Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Registry Population</arm_group_label>
    <description>Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inspire Upper Airway Stimulation System</intervention_name>
    <description>Implant of the Inspire Upper Airway Stimulation System</description>
    <arm_group_label>Registry Population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper&#xD;
        Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep&#xD;
        apnea (OSA).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is between 18 and 21 years of age;&#xD;
&#xD;
          2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent&#xD;
             sleep study;&#xD;
&#xD;
          3. Subject has documented failure of, or intolerance to, positive airway pressure&#xD;
             treatments, despite attempts to improve compliance;&#xD;
&#xD;
          4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;&#xD;
&#xD;
          5. Subject has followed standard of care in considering all other alternative/adjunct&#xD;
             therapies;&#xD;
&#xD;
          6. Subject is willing and able to have stimulation hardware permanently implanted and to&#xD;
             use the patient remote to activate the stimulation;&#xD;
&#xD;
          7. Subject is willing and able to return for follow-up visits, undergo sleep studies&#xD;
             (including in-lab and at-home), and complete questionnaires related to the registry;&#xD;
&#xD;
          8. Subject is willing and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a combination of central + mixed apneas &gt; 25% of the total apnea-hypopnea&#xD;
             index (AHI);&#xD;
&#xD;
          2. Subject has any anatomical finding that would compromise the performance of upper&#xD;
             airway stimulation, such as the presence of complete concentric collapse of the soft&#xD;
             palate;&#xD;
&#xD;
          3. Subject has any condition or procedure that has compromised neurological control of&#xD;
             the upper airway;&#xD;
&#xD;
          4. Subject is unable, or does not have the necessary assistance, to operate the patient&#xD;
             remote;&#xD;
&#xD;
          5. Subject is pregnant or plans to become pregnant;&#xD;
&#xD;
          6. Subject has an implantable device that may be susceptible to unintended interaction&#xD;
             with the Inspire System;&#xD;
&#xD;
          7. Subject has a terminal illness with life expectancy &lt; 12 months;&#xD;
&#xD;
          8. Any other reason the investigator deems the subject is unfit for participation in the&#xD;
             registry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gwen Gimmestad</last_name>
    <phone>763-392-9966</phone>
    <email>gwengimmestad@inspiresleep.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mike Swierzewski, MS</last_name>
    <email>michael.swierzewski@inspiresleep.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikhila Raol, MD</last_name>
      <email>Nikhila.Raol@choa.org</email>
    </contact>
    <contact_backup>
      <last_name>Tey Ching Siong</last_name>
      <email>Ching.Siong.tey@emory.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern/Children's Hospital of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ron Mitchell, MD</last_name>
      <email>Ron.Mitchell@UTSouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Francesca Chambers</last_name>
      <email>Francesca.Chambers@childrens.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters/East Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Baldassari, MD</last_name>
      <email>cristina.baldassari@chkd.org</email>
    </contact>
    <contact_backup>
      <last_name>Laura Stone, RN, BSN</last_name>
      <phone>757-388-6238</phone>
      <email>stonelj@evms.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Apnea-hypopnea Index</keyword>
  <keyword>Sleep Breathing Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04457154
org study id: 2020-002
nct id: NCT04457154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is ppsd: Yes
is us export: Yes
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages
      18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System
      for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects
      will be followed for 5 years post-implant.
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages
      18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System
      for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects
      will be followed for 5 years post-implant.

      Subjects will be recruited in accordance with the approved Inspire UAS indication for use and
      will only include those subjects who are within the new age indication (18-21 years of age).
      Implanted subjects must meet the registry eligibility criteria. Those subjects that are
      enrolled but fail to meet the eligibility criteria will be considered screen failures.

      This registry will collect safety and effectiveness data on 60 implanted subjects at a
      minimum of 5 qualified clinical centers in the United States.

      Study data will be collected at the following timepoints:

      Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant

      1, 2, 3, 4, 5 years post-implant
observational model: Cohort
time perspective: Prospective
measure: Evaluation of device and/or procedure related adverse events over time
time frame: Implant through 5 years post-implant
description: relevant adverse events will be collected and reported
measure: Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
time frame: through 5 years post-implant
description: Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
measure: Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
time frame: through 5 years post-implant
description: Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.
measure: Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
time frame: through 5 years post-implant
description: Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) < 90%. A lower T90 indicates less severe sleep apnea.
measure: Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
time frame: through 5 years post-implant
description: Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.
arm group label: Registry Population
description: Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)
intervention type: Device
intervention name: Inspire Upper Airway Stimulation System
description: Implant of the Inspire Upper Airway Stimulation System
arm group label: Registry Population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 21 Years
healthy volunteers: No
last name: Gwen Gimmestad
phone: 763-392-9966
email: gwengimmestad@inspiresleep.com
last name: Mike Swierzewski, MS
email: michael.swierzewski@inspiresleep.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided