<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/NCT04416542</url>
  </required_header>
  <id_info>
    <org_study_id>2020-001</org_study_id>
    <nct_id>NCT04416542</nct_id>
  </id_info>
  <brief_title>Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)</brief_title>
  <acronym>HOME</acronym>
  <official_title>Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two&#xD;
      randomization arms, at 6 months post-activation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, randomized, non-blinded, multi-center study of therapy&#xD;
      optimization related to the Inspire UAS System (implanted in a commercial setting under&#xD;
      current labeling).&#xD;
&#xD;
      Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire&#xD;
      UAS system) who undergo different post-implant care algorithms throughout follow-up, in order&#xD;
      to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG&#xD;
      titration in a sub-set of patients.&#xD;
&#xD;
      Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire&#xD;
      UAS system), according to commercial labeling, will be recruited to participate in the study.&#xD;
&#xD;
      A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60&#xD;
      subjects will be randomized (1:1) to one of two study arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">June 10, 2022</completion_date>
  <primary_completion_date type="Actual">June 10, 2022</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>Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>The AHI endpoint will be determined by performing three equivalency tests for the following: Absolute AHI and, change in AHI. All comparisons will be done on the treatment AHI at 6 months between the control group and the home monitoring group. The objective is to demonstrate the equivalence in AHI, change in AHI, and response rate between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>The Epworth Sleepiness Scale (ESS) endpoint will be determined by performing an equivalence test for the ESS score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ESS score to be equivalent between the two groups.&#xD;
H0: |x ̃_diff |&gt;2 Ha: |x ̃_diff |≤2&#xD;
where x ̃_diff is the median of differences (location shift) in the ESS score between the two groups.&#xD;
As the ESS score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -2 and 2 will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>The Oxygen Desaturation Index (ODI) endpoint will be determined by performing an equivalence test for the ODI score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ODI score to be equivalent between the two groups.&#xD;
H0: |x ̃_diff |&gt;15 Ha: |x ̃_diff |≤15 where x ̃_diff is the median of differences (location shift) in the ODI score between the two groups.&#xD;
As the ODI score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. ODI is closely related to AHI and therefore an equivalence margin of -15 and 15 will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Therapy Usage (hours per week), between the two randomization arms</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>The therapy usage endpoint will be determined by performing an equivalence test for the average therapy usage at 6 months between the control group and the home monitoring group. The objective is to demonstrate therapy usage to be equivalent between the two groups.&#xD;
H0: |x ̃_diff |&gt;0.5 hrs Ha: |x ̃_diff |≤0.5 hrs where x ̃_diff is the median of differences (location shift) in therapy usage between the two groups.&#xD;
As the treatment therapy usage at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -0.5 and 0.5 hrs will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this group will be implanted with the Inspire UAS system and will undergo a standard in-lab PSG titration study at approximately 3 months post-activation and a 2-night HST at approximately 6 months post-activation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who have undergone implant of the Inspire UAS System and are randomized to this group will undergo a 2-night HST at 3 months post-activation. Depending on the results of the 2-night HST, the subject will either (a) undergo a PSG titration at 5 months post-activation and a 2-night HST at 6 months post-activation OR (b) undergo only a 2-night HST at approximately 6 months post-activation</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Home Sleep Testing</intervention_name>
    <description>Two-night Home Sleep Tests (HSTs) will be conducted using commercially available Home Sleep Test equipment. The HST will be ordered by the clinical center through a HIPAA compliant HST service that has been selected by the study sponsor.&#xD;
The HSTs will be scored and interpreted according to AASM Guidelines by board certified sleep physicians affiliated with the HST service. The HST will be scored using the 4% oxygen desaturation rule.</description>
    <arm_group_label>Home Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥ 22 years of age;&#xD;
&#xD;
          2. Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant)&#xD;
             AHI ≥ 15 based on a qualified sleep study;&#xD;
&#xD;
          3. Patient has been implanted with the Inspire UAS System but not yet activated, or has&#xD;
             been scheduled for implant of the Inspire UAS System;&#xD;
&#xD;
          4. Patient currently owns a SmartPhone and is willing and able to install and use&#xD;
             SmartPhone apps (at no cost to patient);&#xD;
&#xD;
          5. Patient is willing to utilize study equipment at home including Home Sleep Test (HST)&#xD;
             equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with&#xD;
             the study protocol;&#xD;
&#xD;
          6. Patient is willing and able to return for all follow-up study visits;&#xD;
&#xD;
          7. Patient is willing to be randomized and adhere to randomization allocation;&#xD;
&#xD;
          8. Patient is willing to and capable of providing informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has central + mixed apneas more than &gt; 25% of the total AHI;&#xD;
&#xD;
          2. Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional&#xD;
             therapy) and will not discontinue use of adjunctive therapy upon implant of the&#xD;
             Inspire UAS System;&#xD;
&#xD;
          3. Patient is pregnant or plans to become pregnant;&#xD;
&#xD;
          4. Patient has a terminal illness with life expectancy &lt; 12 months;&#xD;
&#xD;
          5. Any other reason the investigator deems that the patient is unfit for participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Sleep Medicine Institute</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OSA</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>No</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/NCT04416542
org study id: 2020-001
nct id: NCT04416542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two
      randomization arms, at 6 months post-activation
This study is a prospective, randomized, non-blinded, multi-center study of therapy
      optimization related to the Inspire UAS System (implanted in a commercial setting under
      current labeling).

      Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire
      UAS system) who undergo different post-implant care algorithms throughout follow-up, in order
      to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG
      titration in a sub-set of patients.

      Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire
      UAS system), according to commercial labeling, will be recruited to participate in the study.

      A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60
      subjects will be randomized (1:1) to one of two study arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms
time frame: 6 months post-activation
description: The AHI endpoint will be determined by performing three equivalency tests for the following: Absolute AHI and, change in AHI. All comparisons will be done on the treatment AHI at 6 months between the control group and the home monitoring group. The objective is to demonstrate the equivalence in AHI, change in AHI, and response rate between the two groups.
measure: Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms
time frame: 6 months post-activation
description: The Epworth Sleepiness Scale (ESS) endpoint will be determined by performing an equivalence test for the ESS score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ESS score to be equivalent between the two groups.
H0: |x ̃_diff |>2 Ha: |x ̃_diff |≤2
where x ̃_diff is the median of differences (location shift) in the ESS score between the two groups.
As the ESS score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -2 and 2 will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.
measure: Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms
time frame: 6 months post-activation
description: The Oxygen Desaturation Index (ODI) endpoint will be determined by performing an equivalence test for the ODI score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ODI score to be equivalent between the two groups.
H0: |x ̃_diff |>15 Ha: |x ̃_diff |≤15 where x ̃_diff is the median of differences (location shift) in the ODI score between the two groups.
As the ODI score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. ODI is closely related to AHI and therefore an equivalence margin of -15 and 15 will be used.
measure: Comparison of Therapy Usage (hours per week), between the two randomization arms
time frame: 6 months post-activation
description: The therapy usage endpoint will be determined by performing an equivalence test for the average therapy usage at 6 months between the control group and the home monitoring group. The objective is to demonstrate therapy usage to be equivalent between the two groups.
H0: |x ̃_diff |>0.5 hrs Ha: |x ̃_diff |≤0.5 hrs where x ̃_diff is the median of differences (location shift) in therapy usage between the two groups.
As the treatment therapy usage at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -0.5 and 0.5 hrs will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.
arm group label: Control
arm group type: No Intervention
description: Subjects in this group will be implanted with the Inspire UAS system and will undergo a standard in-lab PSG titration study at approximately 3 months post-activation and a 2-night HST at approximately 6 months post-activation
arm group label: Home Monitoring
arm group type: Active Comparator
description: Subjects who have undergone implant of the Inspire UAS System and are randomized to this group will undergo a 2-night HST at 3 months post-activation. Depending on the results of the 2-night HST, the subject will either (a) undergo a PSG titration at 5 months post-activation and a 2-night HST at 6 months post-activation OR (b) undergo only a 2-night HST at approximately 6 months post-activation
intervention type: Diagnostic Test
intervention name: Home Sleep Testing
description: Two-night Home Sleep Tests (HSTs) will be conducted using commercially available Home Sleep Test equipment. The HST will be ordered by the clinical center through a HIPAA compliant HST service that has been selected by the study sponsor.
The HSTs will be scored and interpreted according to AASM Guidelines by board certified sleep physicians affiliated with the HST service. The HST will be scored using the 4% oxygen desaturation rule.
arm group label: Home Monitoring
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No