<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/NCT04425408</url>
  </required_header>
  <id_info>
    <org_study_id>B076201941938</org_study_id>
    <nct_id>NCT04425408</nct_id>
  </id_info>
  <brief_title>Comparison of 2 Different Positional Therapies for Positional Obstructive Sleep Apnea Syndrome</brief_title>
  <official_title>Randomized Cross Over Trial Assessing the Efficacy of Two Different Positional Therapies for Positional Obstructive Sleep Apnea (POSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</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 proposed study is a randomized cross over trial assessing the efficacy of two different&#xD;
      positional therapies for positional obstructive sleep apnea (POSA).&#xD;
&#xD;
      The effectiveness of the two different therapeutic devices (Positional pillow and vibrating&#xD;
      belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be&#xD;
      evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea.&#xD;
&#xD;
      The subjective quality of sleep will also be evaluated prior to treatment and following the&#xD;
      use of each separate device by means of a &quot;Quality of sleep questionnaire&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a de novo diagnosis of positional sleep apnoea on a polysomnography performed&#xD;
      in our sleep lab will be asked to participate to the study. They should fulfill the Mador&#xD;
      definiton of POSA.&#xD;
&#xD;
      A home recording of sleep position with Somnibel Pro will be conduted for 2 consecutive&#xD;
      nights. In case of confirmation of supine sleep at home (Mean supine sleep &gt;30% of total&#xD;
      sleep time) the patient will be asked to use two different positional therapy devices&#xD;
      consecutively (Positional pillow and vibrating belt), 3 nights each, in a random order, with&#xD;
      concomitant recording of sleep position with the Somnibel Pro. Global satisfaction&#xD;
      questionnaire will be assessed by a simple visual analogic scale (is it easy to use? Is it&#xD;
      confortable? Is it efficient on snoring? Is it efficient on sleep apnea? Would you pay for&#xD;
      such treatment? Willingness to use it on a long-term basis?) The subjective sleep quality&#xD;
      will also be assessed by means of &quot;Sleep quality questionnaire&quot;, prior to commencing&#xD;
      treatment, and consecutively after 3 nights on each individual therapy.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Efficacy of Positional pillow (Posiform) and vibrating belt (Somnofit) Percentage sleep on&#xD;
      back on treatment will be compared to mean percentage sleep on back without treatment, at&#xD;
      home, for both devices. Comparison on surrogate AHI based on diagnostic polysomnography, with&#xD;
      and without each device. Global satisfaction with the devices will also be compared between&#xD;
      devices.&#xD;
&#xD;
      The sleep quality will be compared on the two devices using the &quot;Sleep quality&#xD;
      questionnaire&quot;.&#xD;
&#xD;
      The sample size of 52 subjects (26 in each arm), has been calculated to obtain a power of 90%&#xD;
      and allow a drop out rate of 10%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the proportion of supine sleep time without treatment and between the two devices (positional pillow and vibrating belt).</measure>
    <time_frame>5 years</time_frame>
    <description>The percentage of supine sleep on treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Positional Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Positional pillow followed by vibrating belt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 patients with positional sleep apnea will be randomized to spend 3 nights using a positional pillow followed by a vibrating belt. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibrating belt followed by positional pillow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 patients with positional sleep apnea will be randomized to spend 3 nights using a vibrating belt followed by a positional pillow. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Consecutive trial of two different devices for the treatment of positional sleep apnoea, for 3 nights with each device (positional pillow and vibrating belt).</intervention_name>
    <description>Patients will be randomly allocated to use either a positional pillow or a vibrating belt for three consecutive nights at home followed by three nights with the other device.</description>
    <arm_group_label>Positional pillow followed by vibrating belt</arm_group_label>
    <arm_group_label>Vibrating belt followed by positional pillow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients able to give writtent consent with a de novo diagnosis of positional&#xD;
             sleep apnoea according to a polysomnograph.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Bruyneel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Saint Pierre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Bruyneel</last_name>
    <phone>+3225354244</phone>
    <email>marie.bruyneel@stpierre-bru.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre hospitalier universitaire Saint Pierre, Rue Haute 322</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Bruyneel, MD, PhD</last_name>
      <email>marie_bruyneel@stpierre-bru.be</email>
    </contact>
    <contact_backup>
      <last_name>Diana Aguilar, MBBS</last_name>
      <email>diana_aguilar@stpierre-bru.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>February 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Saint Pierre</investigator_affiliation>
    <investigator_full_name>Marie Bruyneel</investigator_full_name>
    <investigator_title>Deputy Head of the Respiratory Unit, Clinical 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>
    <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/NCT04425408
org study id: B076201941938
nct id: NCT04425408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study is a randomized cross over trial assessing the efficacy of two different
      positional therapies for positional obstructive sleep apnea (POSA).

      The effectiveness of the two different therapeutic devices (Positional pillow and vibrating
      belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be
      evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea.

      The subjective quality of sleep will also be evaluated prior to treatment and following the
      use of each separate device by means of a "Quality of sleep questionnaire"
Patients with a de novo diagnosis of positional sleep apnoea on a polysomnography performed
      in our sleep lab will be asked to participate to the study. They should fulfill the Mador
      definiton of POSA.

      A home recording of sleep position with Somnibel Pro will be conduted for 2 consecutive
      nights. In case of confirmation of supine sleep at home (Mean supine sleep >30% of total
      sleep time) the patient will be asked to use two different positional therapy devices
      consecutively (Positional pillow and vibrating belt), 3 nights each, in a random order, with
      concomitant recording of sleep position with the Somnibel Pro. Global satisfaction
      questionnaire will be assessed by a simple visual analogic scale (is it easy to use? Is it
      confortable? Is it efficient on snoring? Is it efficient on sleep apnea? Would you pay for
      such treatment? Willingness to use it on a long-term basis?) The subjective sleep quality
      will also be assessed by means of "Sleep quality questionnaire", prior to commencing
      treatment, and consecutively after 3 nights on each individual therapy.

      Statistical analysis:

      Efficacy of Positional pillow (Posiform) and vibrating belt (Somnofit) Percentage sleep on
      back on treatment will be compared to mean percentage sleep on back without treatment, at
      home, for both devices. Comparison on surrogate AHI based on diagnostic polysomnography, with
      and without each device. Global satisfaction with the devices will also be compared between
      devices.

      The sleep quality will be compared on the two devices using the "Sleep quality
      questionnaire".

      The sample size of 52 subjects (26 in each arm), has been calculated to obtain a power of 90%
      and allow a drop out rate of 10%.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of the proportion of supine sleep time without treatment and between the two devices (positional pillow and vibrating belt).
time frame: 5 years
description: The percentage of supine sleep on treatment
arm group label: Positional pillow followed by vibrating belt
arm group type: Experimental
description: 26 patients with positional sleep apnea will be randomized to spend 3 nights using a positional pillow followed by a vibrating belt. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.
arm group label: Vibrating belt followed by positional pillow
arm group type: Experimental
description: 26 patients with positional sleep apnea will be randomized to spend 3 nights using a vibrating belt followed by a positional pillow. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.
intervention type: Device
intervention name: Consecutive trial of two different devices for the treatment of positional sleep apnoea, for 3 nights with each device (positional pillow and vibrating belt).
description: Patients will be randomly allocated to use either a positional pillow or a vibrating belt for three consecutive nights at home followed by three nights with the other device.
arm group label: Positional pillow followed by vibrating belt
arm group label: Vibrating belt followed by positional pillow
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Marie Bruyneel
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Saint Pierre
last name: Marie Bruyneel
phone: +3225354244
email: marie.bruyneel@stpierre-bru.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Saint Pierre
investigator full name: Marie Bruyneel
investigator title: Deputy Head of the Respiratory Unit, Clinical Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No