<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/NCT03277963</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-348</org_study_id>
    <secondary_id>2008-A01045-50</secondary_id>
    <nct_id>NCT03277963</nct_id>
  </id_info>
  <brief_title>Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient</brief_title>
  <official_title>Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major&#xD;
      disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand,&#xD;
      the SAOS could generate pain perception disorders in a population already affected by the&#xD;
      mechanical weight constraints, generating potentially painful complications, and on the other&#xD;
      hand, the improvement of sleep provided by continuous positive airway pressure (PPC)&#xD;
      ventilation could &quot;normalize&quot; the pain perception thresholds. It was shown an early rebound&#xD;
      effect after treatment on increasing pain threshold in the healthy subject. We want to check&#xD;
      it among obese patients with OSA in early and mid-term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this controlled study, patients of both sexes over 18 years of age who are obese with a&#xD;
      body mass index (BMI) of 30 will be included. They will benefit from a polygraphy to confirm&#xD;
      or invalidate the presence of an obstructive sleep apnea syndrome (defined by an&#xD;
      apnea-hypopnea index to 10). Patients will be tested for mechanical and electrical pain&#xD;
      within one week of diagnosis. Among these patients, those with severe SAOS (IAH 30) warrant&#xD;
      treatment with continuous positive airway pressure (usual procedure). They will be&#xD;
      hospitalized for the implementation of this treatment (usual procedure) and subjected to&#xD;
      mechanical and electrical pain tests on the second day after the treatment is put in place.&#xD;
&#xD;
      One month after the start of treatment, they will benefit from an ambulatory polygraph test&#xD;
      (usual procedure) as well as mechanical and electrical pain tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2010</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 1, 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>scales of pain</measure>
    <time_frame>at day 1</time_frame>
    <description>sensibility, detection, tolerance</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Obesity</condition>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Absence of sleep apnea syndrome</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pain perception tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presence of sleep apnea syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)</intervention_name>
    <description>From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression.</description>
    <arm_group_label>Absence of sleep apnea syndrome</arm_group_label>
    <arm_group_label>Presence of sleep apnea syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age,&#xD;
&#xD;
          -  male or female,&#xD;
&#xD;
          -  obesity defined by a body mass index (BMI = weight in kg / height in m²) ≥ 30,&#xD;
&#xD;
          -  free from acute or chronic painful pathology,&#xD;
&#xD;
          -  free from any chronic analgesic treatment,&#xD;
&#xD;
          -  free from any psychotropic treatment by benzodiazepine and / or tricyclic&#xD;
             antidepressant,&#xD;
&#xD;
          -  presence of obstructive sleep apnea syndrome (with apnea-hypopnea index (IAH) 10 per&#xD;
             hour of sleep) among 60 patients,&#xD;
&#xD;
          -  absence of obstructive sleep apnea syndrome (IAH &lt;10 per hour of sleep) among 60&#xD;
             patients,&#xD;
&#xD;
          -  person who signed the information and consent form,&#xD;
&#xD;
          -  patients who have been screened for sleep apnea syndrome by Somnochek® negative (AHI&#xD;
             &lt;10 / h) in the last 6 months, provided that their weight is the same or lower at the&#xD;
             time of inclusion,&#xD;
&#xD;
          -  Somnochek® sleep apnea syndrome screening positive and severe for hospitalization&#xD;
             (IAH&gt; 30 / h) in the last 3 months, provided that their weight is the same or higher&#xD;
             at the time of inclusion.&#xD;
&#xD;
        In addition, the 23 patients in the subgroup with severe OSA must meet the following&#xD;
        criteria:&#xD;
&#xD;
          -  presence of obstructive sleep apnea syndrome (with apnea-hypopnea index (IAH) 30 per&#xD;
             hour of sleep) among 23 patients,&#xD;
&#xD;
          -  acceptance of treatment with PCC,&#xD;
&#xD;
          -  availability to come to the CHU for the control of pain threshold perception tests one&#xD;
             month after the introduction of PPC treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  difficulties in understanding and speaking French,&#xD;
&#xD;
          -  an alcohol abuse or dependence (DSM-IV),&#xD;
&#xD;
          -  an abuse or dependence on illicit drugs (DSM-IV),&#xD;
&#xD;
          -  an acute or chronic inflammatory pathology,&#xD;
&#xD;
          -  a neuro-muscular pathology,&#xD;
&#xD;
          -  clinical signs of right heart failure,&#xD;
&#xD;
          -  an analgesic treatment,&#xD;
&#xD;
          -  treatment with benzodiazepines and / or tricyclic antidepressants, a β-blocking&#xD;
             treatment,&#xD;
&#xD;
          -  Central sleep apnea,&#xD;
&#xD;
          -  person who is absent from another study or who has received more than 4500 euros in&#xD;
             the year following his participation in clinical studies,&#xD;
&#xD;
          -  pregnant or nursing women,&#xD;
&#xD;
          -  person under tutelage or deprived of his rights,&#xD;
&#xD;
          -  refusal to sign the information and consent form.&#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>Magalie MIOLANNE-DEBOUIT, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Obstructive sleep apnea syndrome</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>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03277963
org study id: CHU-348
secondary id: 2008-A01045-50
nct id: NCT03277963
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major
      disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand,
      the SAOS could generate pain perception disorders in a population already affected by the
      mechanical weight constraints, generating potentially painful complications, and on the other
      hand, the improvement of sleep provided by continuous positive airway pressure (PPC)
      ventilation could "normalize" the pain perception thresholds. It was shown an early rebound
      effect after treatment on increasing pain threshold in the healthy subject. We want to check
      it among obese patients with OSA in early and mid-term.
In this controlled study, patients of both sexes over 18 years of age who are obese with a
      body mass index (BMI) of 30 will be included. They will benefit from a polygraphy to confirm
      or invalidate the presence of an obstructive sleep apnea syndrome (defined by an
      apnea-hypopnea index to 10). Patients will be tested for mechanical and electrical pain
      within one week of diagnosis. Among these patients, those with severe SAOS (IAH 30) warrant
      treatment with continuous positive airway pressure (usual procedure). They will be
      hospitalized for the implementation of this treatment (usual procedure) and subjected to
      mechanical and electrical pain tests on the second day after the treatment is put in place.

      One month after the start of treatment, they will benefit from an ambulatory polygraph test
      (usual procedure) as well as mechanical and electrical pain tests.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: scales of pain
time frame: at day 1
description: sensibility, detection, tolerance
arm group label: Absence of sleep apnea syndrome
arm group type: Active Comparator
description: Pain perception tests
arm group label: Presence of sleep apnea syndrome
arm group type: Experimental
description: Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation
intervention type: Device
intervention name: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)
description: From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression.
arm group label: Absence of sleep apnea syndrome
arm group label: Presence of sleep apnea syndrome
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Magalie MIOLANNE-DEBOUIT, PH
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome