<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/NCT02979184</url>
  </required_header>
  <id_info>
    <org_study_id>38RC16.204</org_study_id>
    <nct_id>NCT02979184</nct_id>
  </id_info>
  <brief_title>Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy</brief_title>
  <acronym>LYMPHOS</acronym>
  <official_title>Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a&#xD;
      decrease in the amount of liquid of the affected limb, with movement of the intracellular&#xD;
      liquid towards the trunk and the neck then into the jugular-subclavian confluence, the&#xD;
      superior vena cava and right atrium without modification of extracellular fluid. No study&#xD;
      have evaluated the prevalence of sleep apnea syndrome in this population and the effect of&#xD;
      this treatment on sleep apnea syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema is the result of an intra-tissue fluid accumulation by failure of the lymphatic&#xD;
      system to absorb the excess fluid from the veinulo-capillary circulation. Lymphedema can be&#xD;
      primitive with aplasia or hypoplasia of the lymphatic vessels or secondary by destruction of&#xD;
      the lymphatic structures.&#xD;
&#xD;
      We define three stages of severity of lymphedema:&#xD;
&#xD;
        -  Stage I: increase of volume which is mitigate when the limb is raised&#xD;
&#xD;
        -  Stage II: the elevation does not reduce anymore the volume and the oedema is still&#xD;
           compressible. It produces skin changes such as fibrosis, rendered by the sign of&#xD;
           Stemmer.&#xD;
&#xD;
        -  Stage III: elephantiasis with disappearance of the compressible nature of edema,&#xD;
           appearance of trophic skin disorders (papillomas, vesicles) and nail disorders.&#xD;
&#xD;
      The first-line treatment of lymphedema corresponds to a physical therapy by decongestive&#xD;
      physiotherapy. This intensive rehabilitation includes sessions of manual lymphatic drainages&#xD;
      or pressure therapy sessions followed by the application of inelastic multilayer bandages,&#xD;
      muscle exercises under bandages, skin care and pedicure for lymphedema of the lower limbs.&#xD;
&#xD;
      Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a&#xD;
      decrease in the amount of liquid of the affected limb, with movement of the intracellular&#xD;
      liquid towards the trunk and the neck then into the jugular-subclavian confluence, the&#xD;
      superior vena cava and right atrium without modification of extracellular fluid. No study&#xD;
      have evaluated the prevalence of sleep apnea syndrome in this population and the effect of&#xD;
      this treatment on sleep apnea syndrome.&#xD;
&#xD;
      The interest of this study is to evaluate the prevalence of sleep apnea syndrome at patients&#xD;
      suffering from lymphedema and the effect of intensive decongestive physiotherapy on the&#xD;
      syndrome of sleep apnea by modification of the fluid redistribution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.</measure>
    <time_frame>1 year</time_frame>
    <description>Apnea/hypopnea index (AHI /h) measured by Apnea-Link or antecedent of Obstructive sleep apnea syndrom already treated with CPAP (Continuous Positive Airway Pressure) ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5</measure>
    <time_frame>1 year</time_frame>
    <description>Apnea/hypopnea index (AHI / h) before and after intensive decongestive physiotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of clinical signs associated with sleep apnea after rehabilitation</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical signs associated with sleep apnea: snoring, feeling of suffocation or oppression during sleep, non-restorative sleep, daytime fatigue, concentration difficulties, nocturia (clinical questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement of limb perimeters (volumetry) before and after rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.</measure>
    <time_frame>1 year</time_frame>
    <description>Score of the Epworth sleepiness scale before and after rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.</measure>
    <time_frame>1 year</time_frame>
    <description>Score in the MOS-SF-36 questionnaire before and after rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between BMI (Body Mass Index) and apnea/hypopnea index.</measure>
    <time_frame>1 year</time_frame>
    <description>BMI (kg/m^2)before and after rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between perimeter of the neck and apnea/hypopnea index</measure>
    <time_frame>1 year</time_frame>
    <description>Neck circumference (cm) before and after rehabilitation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Lymphedema</condition>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Intensive decongestive physiotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>2 weeks of intensive decongestive physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive decongestive physiotherapy</intervention_name>
    <description>2 weeks of intensive decongestive physiotherapy</description>
    <arm_group_label>Intensive decongestive physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lymphedema of one or several limbs (with difference of more than 2 cms compared with&#xD;
             the collateral limb) without contraindication in an intensive decongestive&#xD;
             physiotherapy.&#xD;
&#xD;
          -  Patient member to the social security or beneficiary of such a regime.&#xD;
&#xD;
          -  Patient having signed the informed consent for participation to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical Contraindication in an intensive decongestive physiotherapy : Acute infectious&#xD;
             episode (Erysipelas, lymphangitis), acute venous thrombosis, uncontrolled heart&#xD;
             failure or hypertension, acute renal failure, obstruction of the superior vena cava,&#xD;
             evolutionary untreated malignant tumor, peripheral arterial disease with ankle&#xD;
             brachial indices w&lt; 0,5, evolved diabetic angiopathy, septic thrombosis, popliteal&#xD;
             aneurysm.&#xD;
&#xD;
          -  Patients deprived of freedom by court or admninistrative order. Person being the&#xD;
             object of a legal protective measure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Béatrice VILLEMUR, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUGA</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lymphedema, Obstructive Sleep Apnea , Intensive Decongestive Physiotherapy</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>Lymphedema</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/NCT02979184
org study id: 38RC16.204
nct id: NCT02979184
lead sponsor: 
has dmc: No
Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a
      decrease in the amount of liquid of the affected limb, with movement of the intracellular
      liquid towards the trunk and the neck then into the jugular-subclavian confluence, the
      superior vena cava and right atrium without modification of extracellular fluid. No study
      have evaluated the prevalence of sleep apnea syndrome in this population and the effect of
      this treatment on sleep apnea syndrome.
Lymphedema is the result of an intra-tissue fluid accumulation by failure of the lymphatic
      system to absorb the excess fluid from the veinulo-capillary circulation. Lymphedema can be
      primitive with aplasia or hypoplasia of the lymphatic vessels or secondary by destruction of
      the lymphatic structures.

      We define three stages of severity of lymphedema:

        -  Stage I: increase of volume which is mitigate when the limb is raised

        -  Stage II: the elevation does not reduce anymore the volume and the oedema is still
           compressible. It produces skin changes such as fibrosis, rendered by the sign of
           Stemmer.

        -  Stage III: elephantiasis with disappearance of the compressible nature of edema,
           appearance of trophic skin disorders (papillomas, vesicles) and nail disorders.

      The first-line treatment of lymphedema corresponds to a physical therapy by decongestive
      physiotherapy. This intensive rehabilitation includes sessions of manual lymphatic drainages
      or pressure therapy sessions followed by the application of inelastic multilayer bandages,
      muscle exercises under bandages, skin care and pedicure for lymphedema of the lower limbs.

      Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a
      decrease in the amount of liquid of the affected limb, with movement of the intracellular
      liquid towards the trunk and the neck then into the jugular-subclavian confluence, the
      superior vena cava and right atrium without modification of extracellular fluid. No study
      have evaluated the prevalence of sleep apnea syndrome in this population and the effect of
      this treatment on sleep apnea syndrome.

      The interest of this study is to evaluate the prevalence of sleep apnea syndrome at patients
      suffering from lymphedema and the effect of intensive decongestive physiotherapy on the
      syndrome of sleep apnea by modification of the fluid redistribution.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prevalence of obstructive sleep apnea syndrom in patients with lymphedema, admitted for intensive decongestive physiotherapy.
time frame: 1 year
description: Apnea/hypopnea index (AHI /h) measured by Apnea-Link or antecedent of Obstructive sleep apnea syndrom already treated with CPAP (Continuous Positive Airway Pressure) ventilation
measure: Effect of intensive decongestive physiotherapy on the severity of the obstructive sleep apnea syndrom of patients with apnea/hypopnea index ≥ 5
time frame: 1 year
description: Apnea/hypopnea index (AHI / h) before and after intensive decongestive physiotherapy.
measure: Evolution of clinical signs associated with sleep apnea after rehabilitation
time frame: 1 year
description: Clinical signs associated with sleep apnea: snoring, feeling of suffocation or oppression during sleep, non-restorative sleep, daytime fatigue, concentration difficulties, nocturia (clinical questionnaire)
measure: Correlation between the volume of lymphedema of the suffering limb and the apnea/hypopnea index.
time frame: 1 year
description: Measurement of limb perimeters (volumetry) before and after rehabilitation
measure: Correlation between sleepiness measured by the Epworth scale before and after therapy, and the change in volume of lymphedema.
time frame: 1 year
description: Score of the Epworth sleepiness scale before and after rehabilitation
measure: Correlation between the quality of life as measured by the Medical Outcome Study Short Form questionnaire before and after rehabilitation, and apnea/hypopnea index.
time frame: 1 year
description: Score in the MOS-SF-36 questionnaire before and after rehabilitation
measure: Correlation between BMI (Body Mass Index) and apnea/hypopnea index.
time frame: 1 year
description: BMI (kg/m^2)before and after rehabilitation
measure: Correlation between perimeter of the neck and apnea/hypopnea index
time frame: 1 year
description: Neck circumference (cm) before and after rehabilitation
arm group label: Intensive decongestive physiotherapy
arm group type: Other
description: 2 weeks of intensive decongestive physiotherapy
intervention type: Other
intervention name: Intensive decongestive physiotherapy
description: 2 weeks of intensive decongestive physiotherapy
arm group label: Intensive decongestive physiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Béatrice VILLEMUR, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Lymphedema
sharing ipd: No