<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/NCT03753971</url>
  </required_header>
  <id_info>
    <org_study_id>19121997</org_study_id>
    <secondary_id>2018-02033</secondary_id>
    <nct_id>NCT03753971</nct_id>
  </id_info>
  <brief_title>Early Sleep Apnea Termination Using Sound Stimulation</brief_title>
  <acronym>ESAT</acronym>
  <official_title>Early Sleep Apnea Termination Using Sound Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raphael Heinzer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</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>
      Current evidence suggest that sleep apnea-associated oxygen desaturations may induce&#xD;
      cardiovascular morbidities in the long term, whereas arousals associated with sleep apneas&#xD;
      seem to induce mainly transient nocturnal hypertension. Reducing the occurrence and the&#xD;
      magnitude of sleep apnea-associated oxygen desaturations could therefore have a beneficial&#xD;
      effect on sleep apnea-associated comobidities. Since sleep apneas usually end with an arousal&#xD;
      allowing pharyngeal muscles reactivation, a treatment option could consist of generating an&#xD;
      early short awakening to anticipate apnea termination and decrease the risk of oxygen&#xD;
      desaturation. The aim of this study is thus to determine if an early sleep apnea termination&#xD;
      through the emission of a sound can achieve lower oxygen desaturations compared with&#xD;
      &quot;untreated&quot; sleep apneas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to determine the effect of short sound stimulations on sleep apnea&#xD;
      associated desaturations&#xD;
&#xD;
      20 OSA subjects will be recruited and studied with polysomnography and a head band allowing&#xD;
      to emit short sound stimulations during sleep. the study will take nplace at the Center for&#xD;
      investigation and research in sleep (CIRS)&#xD;
&#xD;
      The magnitude of oxygen desaturations following apnea with and without sound stimulations&#xD;
      will be compared. The effects of different types of sound stimulations on the magnitude of&#xD;
      cortical and autonomic reactions will also be studied as well as the patients' subjective&#xD;
      perception of the sounds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in sleep apnea associted oxygen desaturations</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of the apnea (seconds)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Duration of breathing cessation assessed by nasal cannula (in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of sound stimulations associated with cortical and subcortical arousals (%)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Each arousal will be assessed using the polysomnography EEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of sound stimulations associated with autonomic arousals (%)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Autonomic arousals will be assessed by pulse wave amplitude variations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of autonomic reactions (% of pulse wave amplitude drop)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of EEG arousals (in seconds)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Duration (in seconds) of EEG arousals following different types of sound stimulations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of autonomic reactions (duration of pulse wave amplitude drop)</measure>
    <time_frame>During the polysomnography night</time_frame>
    <description>Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients' perception of the sounds emitted during sleep (visual analog scale 0-10)</measure>
    <time_frame>Morning after the polysomnography night</time_frame>
    <description>Perception of the sound stimulations (number per night)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients' tolerance to the sounds (visual analog scale 0-10)</measure>
    <time_frame>Morning after the polysomnography</time_frame>
    <description>VAS scale reflecting the annoyance associted with the sounds emitted during their sleep</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Apneas with and without intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will be his own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sound stimulation</intervention_name>
    <description>Short sound stimulations will be emitted through a head band during sleep apneas</description>
    <arm_group_label>Apneas with and without intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to give informed consent as documented by signature&#xD;
&#xD;
          -  Apnea / hypopnea index &gt; 30 / h (severe)&#xD;
&#xD;
          -  Obstructive Apnea Index &gt; 15 / h&#xD;
&#xD;
          -  Mean amplitude of desaturations (during diagnostic night) ≥ 5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perception deafness&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc.,&#xD;
&#xD;
          -  Professional drivers&#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>Raphael Heinzer, Pr.</last_name>
    <role>Study Director</role>
    <affiliation>Centre d'investigation et de recherche sur le sommeil (CHUV)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adrien Waeber</name>
      <address>
        <city>Jouxtens-Mézery</city>
        <state>Vaud</state>
        <zip>1008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Raphael Heinzer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
  </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/NCT03753971
org study id: 19121997
secondary id: 2018-02033
nct id: NCT03753971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current evidence suggest that sleep apnea-associated oxygen desaturations may induce
      cardiovascular morbidities in the long term, whereas arousals associated with sleep apneas
      seem to induce mainly transient nocturnal hypertension. Reducing the occurrence and the
      magnitude of sleep apnea-associated oxygen desaturations could therefore have a beneficial
      effect on sleep apnea-associated comobidities. Since sleep apneas usually end with an arousal
      allowing pharyngeal muscles reactivation, a treatment option could consist of generating an
      early short awakening to anticipate apnea termination and decrease the risk of oxygen
      desaturation. The aim of this study is thus to determine if an early sleep apnea termination
      through the emission of a sound can achieve lower oxygen desaturations compared with
      "untreated" sleep apneas.
The aim of the study is to determine the effect of short sound stimulations on sleep apnea
      associated desaturations

      20 OSA subjects will be recruited and studied with polysomnography and a head band allowing
      to emit short sound stimulations during sleep. the study will take nplace at the Center for
      investigation and research in sleep (CIRS)

      The magnitude of oxygen desaturations following apnea with and without sound stimulations
      will be compared. The effects of different types of sound stimulations on the magnitude of
      cortical and autonomic reactions will also be studied as well as the patients' subjective
      perception of the sounds.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in sleep apnea associted oxygen desaturations
time frame: During the polysomnography night
description: Differences in the magnitude of blood oxygen desaturation between treated and untreated sleep apnea events (in % of SaO2)
measure: Duration of the apnea (seconds)
time frame: During the polysomnography night
description: Duration of breathing cessation assessed by nasal cannula (in seconds)
measure: Percentage of sound stimulations associated with cortical and subcortical arousals (%)
time frame: During the polysomnography night
description: Each arousal will be assessed using the polysomnography EEG
measure: Percentage of sound stimulations associated with autonomic arousals (%)
time frame: During the polysomnography night
description: Autonomic arousals will be assessed by pulse wave amplitude variations
measure: Magnitude of autonomic reactions (% of pulse wave amplitude drop)
time frame: During the polysomnography night
description: Magnitude (% of baseline) of pulse wave amplitude drop following different types of sound stimulations
measure: Duration of EEG arousals (in seconds)
time frame: During the polysomnography night
description: Duration (in seconds) of EEG arousals following different types of sound stimulations
measure: Magnitude of autonomic reactions (duration of pulse wave amplitude drop)
time frame: During the polysomnography night
description: Duration of pulse wave amplitude drop following different types of sound stimulations (in seconds)
measure: Patients' perception of the sounds emitted during sleep (visual analog scale 0-10)
time frame: Morning after the polysomnography night
description: Perception of the sound stimulations (number per night)
measure: Patients' tolerance to the sounds (visual analog scale 0-10)
time frame: Morning after the polysomnography
description: VAS scale reflecting the annoyance associted with the sounds emitted during their sleep
arm group label: Apneas with and without intervention
arm group type: Experimental
description: Each patient will be his own control.
intervention type: Other
intervention name: Sound stimulation
description: Short sound stimulations will be emitted through a head band during sleep apneas
arm group label: Apneas with and without intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raphael Heinzer, Pr.
role: Study Director
affiliation: Centre d'investigation et de recherche sur le sommeil (CHUV)
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Raphael Heinzer
investigator title: Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
sharing ipd: No