<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/NCT03756805</url>
  </required_header>
  <id_info>
    <org_study_id>UAS vs. CPAP</org_study_id>
    <nct_id>NCT03756805</nct_id>
  </id_info>
  <brief_title>Upper Airway Stimulation Versus Continuous Positive Airway Pressure</brief_title>
  <official_title>Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway&#xD;
      pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative&#xD;
      treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been&#xD;
      developed since several years. The aim of this clinical trial is to compare both treatments&#xD;
      with each other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA).&#xD;
      During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing&#xD;
      depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to&#xD;
      obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor&#xD;
      respiratory changes such as hypopneas or flow limitations. The symptoms of this disease&#xD;
      manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and&#xD;
      increased risk of cardiovascular disease can result. A significant reduction in overall&#xD;
      quality of life can be associated with OSAS. The gold standard treatment for obstructive&#xD;
      sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of&#xD;
      patients continue to use their device after 2 years of initial CPAP therapy. This means that&#xD;
      30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain&#xD;
      proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP&#xD;
      from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy&#xD;
      option.&#xD;
&#xD;
      Therefore the patient receives surgically a subcutaneous stimulation device under the&#xD;
      clavicle, which receives a signal from a respiratory sensor to selectively stimulate the&#xD;
      hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space&#xD;
      between the patient's external and internal rib muscles. This can be used to record the&#xD;
      patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual&#xD;
      stimulation lead is attached to the medial branches of the hypoglossal nerve, which are&#xD;
      responsible for the protrusion of the tongue, in order to enable appropriate stimulation.&#xD;
&#xD;
      In this prospective cohort study, selective upper airway stimulation (UAS) will now be&#xD;
      compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who&#xD;
      receive an upper airway stimulation. Both methods are procedures established in clinical&#xD;
      routine, and during this investigation, the general clinical course is not deviated.&#xD;
      Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy&#xD;
      is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so&#xD;
      that a surgical concept is justified. The CPAP group should comply with the body mass index&#xD;
      and age of the UAS group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AHI</measure>
    <time_frame>reduction from baseline to 12 months</time_frame>
    <description>Apnea Hypopnea Index measured in events per hour</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ODI</measure>
    <time_frame>reduction from baseline to 12 months</time_frame>
    <description>Oxygen desaturation index measured in events per hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ESS</measure>
    <time_frame>improvement from baseline to 12 months</time_frame>
    <description>Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FOSQ</measure>
    <time_frame>improvement from baseline to 12 months</time_frame>
    <description>Functional Outcome of Sleep Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage</measure>
    <time_frame>usage hours per night at 12 months</time_frame>
    <description>Usage Hour per Night</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">227</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Group 1 (CPAP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient, who are receiving a CPAP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (UAS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient, who are receiving a device for upper airway stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>upper airway stimulation</intervention_name>
    <description>One group of patients with UAS</description>
    <arm_group_label>Group 2 (UAS)</arm_group_label>
    <other_name>Inspire</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>continuous positive airway pressure</intervention_name>
    <description>One group of patients with CPAP</description>
    <arm_group_label>Group 1 (CPAP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive patients who either received UAS implantation (Inspire therapy) in our&#xD;
             Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der&#xD;
             Isar and all patients who received a CPAP therapy since July 2013, are invited to&#xD;
             participate in this clinical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with the age under 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Technical University of Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81667</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>hypoglossal nerve stimulation</keyword>
  <keyword>upper airway stimulation</keyword>
  <keyword>surgical treatment sleep apnea</keyword>
  <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/NCT03756805
org study id: UAS vs. CPAP
nct id: NCT03756805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway
      pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative
      treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been
      developed since several years. The aim of this clinical trial is to compare both treatments
      with each other.
6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA).
      During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing
      depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to
      obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor
      respiratory changes such as hypopneas or flow limitations. The symptoms of this disease
      manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and
      increased risk of cardiovascular disease can result. A significant reduction in overall
      quality of life can be associated with OSAS. The gold standard treatment for obstructive
      sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of
      patients continue to use their device after 2 years of initial CPAP therapy. This means that
      30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain
      proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP
      from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy
      option.

      Therefore the patient receives surgically a subcutaneous stimulation device under the
      clavicle, which receives a signal from a respiratory sensor to selectively stimulate the
      hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space
      between the patient's external and internal rib muscles. This can be used to record the
      patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual
      stimulation lead is attached to the medial branches of the hypoglossal nerve, which are
      responsible for the protrusion of the tongue, in order to enable appropriate stimulation.

      In this prospective cohort study, selective upper airway stimulation (UAS) will now be
      compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who
      receive an upper airway stimulation. Both methods are procedures established in clinical
      routine, and during this investigation, the general clinical course is not deviated.
      Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy
      is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so
      that a surgical concept is justified. The CPAP group should comply with the body mass index
      and age of the UAS group.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.
primary purpose: Treatment
masking: None (Open Label)
measure: AHI
time frame: reduction from baseline to 12 months
description: Apnea Hypopnea Index measured in events per hour
measure: ODI
time frame: reduction from baseline to 12 months
description: Oxygen desaturation index measured in events per hour
measure: ESS
time frame: improvement from baseline to 12 months
description: Epworth Sleepiness Scale
measure: FOSQ
time frame: improvement from baseline to 12 months
description: Functional Outcome of Sleep Questionnaire
measure: Usage
time frame: usage hours per night at 12 months
description: Usage Hour per Night
arm group label: Group 1 (CPAP)
arm group type: Active Comparator
description: Patient, who are receiving a CPAP
arm group label: Group 2 (UAS)
arm group type: Experimental
description: Patient, who are receiving a device for upper airway stimulation
intervention type: Device
intervention name: upper airway stimulation
description: One group of patients with UAS
arm group label: Group 2 (UAS)
other name: Inspire
intervention type: Device
intervention name: continuous positive airway pressure
description: One group of patients with CPAP
arm group label: Group 1 (CPAP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No