<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/NCT03763682</url>
  </required_header>
  <id_info>
    <org_study_id>BETTER SLEEP</org_study_id>
    <nct_id>NCT03763682</nct_id>
  </id_info>
  <brief_title>BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse</brief_title>
  <acronym>BETTER SLEEP</acronym>
  <official_title>A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nyxoah S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nyxoah S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to explore the safety and performance of the Genio™ system in&#xD;
      adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse&#xD;
      of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery)&#xD;
      measured by the AHI, at rest to determine if there is a difference in performance between the&#xD;
      two populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-label, multicentric, 2 groups study to assess the safety and&#xD;
      performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and&#xD;
      without complete concentric collapse of the soft palate. Participants will be consented,&#xD;
      enrolled and eligibility criteria checked. If the participant is eligible, participant will&#xD;
      proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will&#xD;
      be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5&#xD;
      and Month 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">June 28, 2021</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>
    <intervention_model_description>prospective, open-label, 2 groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of serious device-related adverse events recorded during the study</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)</measure>
    <time_frame>Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)</measure>
    <time_frame>6,12, 24, 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)</measure>
    <time_frame>12, 24, 36 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Therapy response rate</measure>
    <time_frame>6, 12, 24, 36 months</time_frame>
    <description>Response is defined as a reduction in AHI from baseline to 6 months of 50% or higher and apnoea-hypopnea index (AHI) at 6 months less than 20.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score</measure>
    <time_frame>6, 12, 24, 36 months</time_frame>
    <description>The questionnaire assesses the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life. It uses a 4-point Likert response format (1= extreme difficulty to 4=no difficulty) for 5 subscales: 1) activity level (3 items), 2) vigilance(3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item). A total score is calculated and an increase is considered an improvement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>6, 12, 24, 36 months</time_frame>
    <description>The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. A reduction in ESS is considered a better outcome with a decrease of 2 points considered to be clinically significant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to 6 months post implantation in snoring intensity</measure>
    <time_frame>6, 12, 24, 36 months</time_frame>
    <description>Measured subjectively by the bed partner using a 5 point scale of no scoring, light snoring, medium snoring, very loud snoring, to leaving the bedroom.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Genio(TM) system therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Genio(TM) bilateral hypoglossal nerve stimulation system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Genio(TM) bilateral hypoglossal nerve stimulation system</intervention_name>
    <description>Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation</description>
    <arm_group_label>Genio(TM) system therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman between 21 and 75 years of age&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 32 kg/m2&#xD;
&#xD;
          -  Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour&#xD;
&#xD;
          -  Participants who have either not tolerated, have failed or refused positive airway&#xD;
             pressure (PAP) treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or incapable of providing informed written consent&#xD;
&#xD;
          -  Unwilling or incapable of returning to all follow-up visits and sleep studies,&#xD;
             including evaluation procedures and filling out questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Westmead Private Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wollongong Private Hospital</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Breathing and Sleep Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hollywood Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6005</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</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>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <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/NCT03763682
org study id: BETTER SLEEP
nct id: NCT03763682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to explore the safety and performance of the Genio™ system in
      adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse
      of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery)
      measured by the AHI, at rest to determine if there is a difference in performance between the
      two populations.
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and
      performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and
      without complete concentric collapse of the soft palate. Participants will be consented,
      enrolled and eligibility criteria checked. If the participant is eligible, participant will
      proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will
      be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5
      and Month 6.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective, open-label, 2 groups
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of serious device-related adverse events recorded during the study
time frame: 6 months
measure: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
time frame: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
measure: Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
time frame: 6,12, 24, 36 months
measure: Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
time frame: 12, 24, 36 months
measure: Therapy response rate
time frame: 6, 12, 24, 36 months
description: Response is defined as a reduction in AHI from baseline to 6 months of 50% or higher and apnoea-hypopnea index (AHI) at 6 months less than 20.
measure: Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score
time frame: 6, 12, 24, 36 months
description: The questionnaire assesses the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life. It uses a 4-point Likert response format (1= extreme difficulty to 4=no difficulty) for 5 subscales: 1) activity level (3 items), 2) vigilance(3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item). A total score is calculated and an increase is considered an improvement.
measure: Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)
time frame: 6, 12, 24, 36 months
description: The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. A reduction in ESS is considered a better outcome with a decrease of 2 points considered to be clinically significant.
measure: Change from baseline to 6 months post implantation in snoring intensity
time frame: 6, 12, 24, 36 months
description: Measured subjectively by the bed partner using a 5 point scale of no scoring, light snoring, medium snoring, very loud snoring, to leaving the bedroom.
arm group label: Genio(TM) system therapy
arm group type: Experimental
description: Genio(TM) bilateral hypoglossal nerve stimulation system
intervention type: Device
intervention name: Genio(TM) bilateral hypoglossal nerve stimulation system
description: Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
arm group label: Genio(TM) system therapy
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No