<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/NCT03753854</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0784</org_study_id>
    <secondary_id>2017-A03352-51</secondary_id>
    <nct_id>NCT03753854</nct_id>
  </id_info>
  <brief_title>Sleep Apnea in Sickle Cell Disease</brief_title>
  <acronym>DREPAPNEE</acronym>
  <official_title>Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell&#xD;
      population, studies focusing on the associations of the two diseases and their common&#xD;
      pathophysiological mechanisms are scarce. OSA is one of the most common conditions&#xD;
      responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in&#xD;
      some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization&#xD;
      and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence&#xD;
      increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative&#xD;
      stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients,&#xD;
      could increase the risk for complications. Finally, OSA is accompanied by impaired vascular&#xD;
      function and autonomic nervous system dysfunction in the general population. Indeed, the&#xD;
      presence of OSA in SCD could increase the clinical severity of patients and the frequency of&#xD;
      VOC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">May 28, 2018</start_date>
  <completion_date type="Actual">November 29, 2021</completion_date>
  <primary_completion_date type="Actual">November 29, 2021</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of VOC crises required hospitalization in the previous two years</measure>
    <time_frame>day 1</time_frame>
    <description>Calculated over a 2 years period before inclusion. VOC requiring hospitalizations will be recorded.&#xD;
Measured at day 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood inflammatory markers</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Blood inflammatory markers : C Reactive Protein (CRP, mg/L) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood inflammatory markers</measure>
    <time_frame>Day 365</time_frame>
    <description>Blood inflammatory markers : C Reactive Protein (CRP, mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of blood coagulation</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Biological risk factors of VOC : prothrombin time (PT, s), D-dimer (µg/L), Fibrinogen (g/L), Activated Thromboplastin Time (APPT, s), protein C and protein S (%) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of blood coagulation</measure>
    <time_frame>Day 365</time_frame>
    <description>prothrombin time (PT, s), D-dimer (µg/L), Fibrinogen (g/L), Activated Thromboplastin Time (APPT, s), protein C and protein S (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cell counts and markers of hemolysis</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Biological risk factors of VOC : Blood cell counts and markers of hemolysis : red blood cell count (G/L), neutrophil count (G/L), hemoglobin concentration (g/dL), hematocrit (%), mean corpuscular volume (MCV, fl), mean corpuscular hemoglobin concentration (MCHC, pg), platelet count (G/L), lactate dehydrogenase (LDH, IU), bilirubin (µg/L), aspartate transaminase (AST, U/L).&#xD;
The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cell counts and markers of hemolysis</measure>
    <time_frame>Day 365</time_frame>
    <description>Blood cell counts and markers of hemolysis : red blood cell count (G/L), neutrophil count (G/L), hemoglobin concentration (g/dL), hematocrit (%), mean corpuscular volume (MCV, fl), mean corpuscular hemoglobin concentration (MCHC, pg), platelet count (G/L), lactate dehydrogenase (LDH, IU), bilirubin (µg/L), aspartate transaminase (AST, U/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of nitric oxide metabolism</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Biological risk factors of VOC : markers of nitric oxide production nitrites, nitrate, nitrotyrosine The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of nitric oxide metabolism</measure>
    <time_frame>Day 365</time_frame>
    <description>markers of nitric oxide production nitrites, nitrate, nitrotyrosine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress markers</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Biological risk factors of VOC : protein oxidation marker (advanced oxidation protein products), markers of lipid peroxidation (malondialdehyde), antioxidant enzymatic activities (super oxide dismutase, catalase, glutathione peroxidase), antioxidant power (ferric reducing ability of plasma) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress markers</measure>
    <time_frame>Day 365</time_frame>
    <description>protein oxidation marker (advanced oxidation protein products), markers of lipid peroxidation (malondialdehyde), antioxidant enzymatic activities (super oxide dismutase, catalase, glutathione peroxidase), antioxidant power (ferric reducing ability of plasma)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorheological parameters</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>blood viscosity (cP) measured with a cone plate viscometer at several shear rates, red blood cell deformability (a.u) measured by ektacytometry at several shear stresses, red blood cell aggregation (%) properties measured by laser backscatter method.&#xD;
The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorheological parameters</measure>
    <time_frame>Day 365</time_frame>
    <description>Biological risk factors of VOC : blood viscosity (cP) measured with a cone plate viscometer at several shear rates, red blood cell deformability (a.u) measured by ektacytometry at several shear stresses, red blood cell aggregation (%) properties measured by laser backscatter method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gases</measure>
    <time_frame>An average of 1 month</time_frame>
    <description>Biological risk factors of VOC : oxygen and carbon dioxide pressure (mmHg), pH The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gases</measure>
    <time_frame>Day 365</time_frame>
    <description>oxygen and carbon dioxide pressure (mmHg), pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function (microvascular reactivity to skin heating test)</measure>
    <time_frame>Day 1</time_frame>
    <description>Physiological risk factors of VOC : A laser Doppler flowmeter (Periflux 5000 Perimed) will be used to measure skin blood flow in resting condition and during a local thermal hyperemia (LTH) test (temperature will be increased from 33 °C to 42 °C) for 35 min. The peak response during the LTH reflects vasodilatation caused by axonal reflex while the delayed plateau response of the LTH test is mainly dependent on the ability to produce nitric oxide to promote vasodilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function (microvascular reactivity to skin heating test)</measure>
    <time_frame>Day 365</time_frame>
    <description>A laser Doppler flowmeter (Periflux 5000 Perimed) will be used to measure skin blood flow in resting condition and during a local thermal hyperemia (LTH) test (temperature will be increased from 33 °C to 42 °C) for 35 min. The peak response during the LTH reflects vasodilatation caused by axonal reflex while the delayed plateau response of the LTH test is mainly dependent on the ability to produce nitric oxide to promote vasodilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>autonomic nervous system activity (measured by heart rate variability analysis)</measure>
    <time_frame>Day 1</time_frame>
    <description>Physiological risk factors of VOC : electrocardiographic signals acquired by the polysomnographic machine will be extracted and the R-R intervals will be used for time domain spectral analyses to calculate several indices reflecting the activity of the autonomic nervous system activity. The ratio between the low frequency and the high frequency powers (LF/HF) will be used to characterize the autonomic imbalance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>autonomic nervous system activity (measured by heart rate variability analysis)</measure>
    <time_frame>Day 365</time_frame>
    <description>electrocardiographic signals acquired by the polysomnographic machine will be extracted and the R-R intervals will be used for time domain spectral analyses to calculate several indices reflecting the activity of the autonomic nervous system activity. The ratio between the low frequency and the high frequency powers (LF/HF) will be used to characterize the autonomic imbalance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of VOC</measure>
    <time_frame>Day 365</time_frame>
    <description>Number of VOC requiring hospitalizations during the past year</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>SS patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Homozygous sickle cell patients&#xD;
Each patient will undergo the following:&#xD;
polysomnography and oxygen saturation exam&#xD;
calculation of VOC rate within the two previous years&#xD;
Blood samples&#xD;
Physiological measurements</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SS patients apneic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Homozygous sickle cell patients after one year of continuous positive airway pressure treatment&#xD;
Each patient will undergo the following:&#xD;
polysomnography and oxygen saturation exam&#xD;
calculation of VOC rate within the two previous years&#xD;
Blood samples&#xD;
Physiological measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>polysomnography and oxygen saturation exam</intervention_name>
    <description>Measurement of the Apnea/hypopnea index (AHI) and oxygen saturation</description>
    <arm_group_label>SS patients</arm_group_label>
    <arm_group_label>SS patients apneic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment</intervention_name>
    <description>calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment</description>
    <arm_group_label>SS patients</arm_group_label>
    <arm_group_label>SS patients apneic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers</description>
    <arm_group_label>SS patients</arm_group_label>
    <arm_group_label>SS patients apneic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiological measurements</intervention_name>
    <description>Evaluation of microvascular reactivity and autonomic nervous system activity</description>
    <arm_group_label>SS patients</arm_group_label>
    <arm_group_label>SS patients apneic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous Positive Airway Pressure</intervention_name>
    <description>Continuous Positive Airway Pressure during 1 year</description>
    <arm_group_label>SS patients apneic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Homozygous HbS (Hemoglobin S) (SS) patients,&#xD;
&#xD;
          -  aged between 15 and 3 months and 50 years old,&#xD;
&#xD;
          -  in steady state (i.e. without vaso-occlusive crisis or recent blood transfusion),&#xD;
&#xD;
          -  followed by the sickle cell center of the Hospices Civils de Lyon,&#xD;
&#xD;
          -  and showing symptoms of OSA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving treatment of OSA,&#xD;
&#xD;
          -  recent blood transfusion (less than 2 months),&#xD;
&#xD;
          -  patients not at steady state (VOC or acute chest syndrome less than 2 months),&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sickle cell disease</keyword>
  <keyword>obstructive sleep apnoea</keyword>
  <keyword>vaso-occlusive crisis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Anemia, Sickle Cell</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/NCT03753854
org study id: 69HCL17_0784
secondary id: 2017-A03352-51
nct id: NCT03753854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell
      population, studies focusing on the associations of the two diseases and their common
      pathophysiological mechanisms are scarce. OSA is one of the most common conditions
      responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in
      some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization
      and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence
      increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative
      stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients,
      could increase the risk for complications. Finally, OSA is accompanied by impaired vascular
      function and autonomic nervous system dysfunction in the general population. Indeed, the
      presence of OSA in SCD could increase the clinical severity of patients and the frequency of
      VOC.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: number of VOC crises required hospitalization in the previous two years
time frame: day 1
description: Calculated over a 2 years period before inclusion. VOC requiring hospitalizations will be recorded.
Measured at day 1
measure: Blood inflammatory markers
time frame: An average of 1 month
description: Blood inflammatory markers : C Reactive Protein (CRP, mg/L) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Blood inflammatory markers
time frame: Day 365
description: Blood inflammatory markers : C Reactive Protein (CRP, mg/L)
measure: Markers of blood coagulation
time frame: An average of 1 month
description: Biological risk factors of VOC : prothrombin time (PT, s), D-dimer (µg/L), Fibrinogen (g/L), Activated Thromboplastin Time (APPT, s), protein C and protein S (%) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Markers of blood coagulation
time frame: Day 365
description: prothrombin time (PT, s), D-dimer (µg/L), Fibrinogen (g/L), Activated Thromboplastin Time (APPT, s), protein C and protein S (%)
measure: Blood cell counts and markers of hemolysis
time frame: An average of 1 month
description: Biological risk factors of VOC : Blood cell counts and markers of hemolysis : red blood cell count (G/L), neutrophil count (G/L), hemoglobin concentration (g/dL), hematocrit (%), mean corpuscular volume (MCV, fl), mean corpuscular hemoglobin concentration (MCHC, pg), platelet count (G/L), lactate dehydrogenase (LDH, IU), bilirubin (µg/L), aspartate transaminase (AST, U/L).
The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Blood cell counts and markers of hemolysis
time frame: Day 365
description: Blood cell counts and markers of hemolysis : red blood cell count (G/L), neutrophil count (G/L), hemoglobin concentration (g/dL), hematocrit (%), mean corpuscular volume (MCV, fl), mean corpuscular hemoglobin concentration (MCHC, pg), platelet count (G/L), lactate dehydrogenase (LDH, IU), bilirubin (µg/L), aspartate transaminase (AST, U/L).
measure: Markers of nitric oxide metabolism
time frame: An average of 1 month
description: Biological risk factors of VOC : markers of nitric oxide production nitrites, nitrate, nitrotyrosine The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Markers of nitric oxide metabolism
time frame: Day 365
description: markers of nitric oxide production nitrites, nitrate, nitrotyrosine
measure: Oxidative stress markers
time frame: An average of 1 month
description: Biological risk factors of VOC : protein oxidation marker (advanced oxidation protein products), markers of lipid peroxidation (malondialdehyde), antioxidant enzymatic activities (super oxide dismutase, catalase, glutathione peroxidase), antioxidant power (ferric reducing ability of plasma) The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Oxidative stress markers
time frame: Day 365
description: protein oxidation marker (advanced oxidation protein products), markers of lipid peroxidation (malondialdehyde), antioxidant enzymatic activities (super oxide dismutase, catalase, glutathione peroxidase), antioxidant power (ferric reducing ability of plasma)
measure: Hemorheological parameters
time frame: An average of 1 month
description: blood viscosity (cP) measured with a cone plate viscometer at several shear rates, red blood cell deformability (a.u) measured by ektacytometry at several shear stresses, red blood cell aggregation (%) properties measured by laser backscatter method.
The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Hemorheological parameters
time frame: Day 365
description: Biological risk factors of VOC : blood viscosity (cP) measured with a cone plate viscometer at several shear rates, red blood cell deformability (a.u) measured by ektacytometry at several shear stresses, red blood cell aggregation (%) properties measured by laser backscatter method.
measure: Arterial blood gases
time frame: An average of 1 month
description: Biological risk factors of VOC : oxygen and carbon dioxide pressure (mmHg), pH The morning after the polysomnography blood samples will be collected (M1 +/- 15 days)
measure: Arterial blood gases
time frame: Day 365
description: oxygen and carbon dioxide pressure (mmHg), pH
measure: Vascular function (microvascular reactivity to skin heating test)
time frame: Day 1
description: Physiological risk factors of VOC : A laser Doppler flowmeter (Periflux 5000 Perimed) will be used to measure skin blood flow in resting condition and during a local thermal hyperemia (LTH) test (temperature will be increased from 33 °C to 42 °C) for 35 min. The peak response during the LTH reflects vasodilatation caused by axonal reflex while the delayed plateau response of the LTH test is mainly dependent on the ability to produce nitric oxide to promote vasodilation.
measure: Vascular function (microvascular reactivity to skin heating test)
time frame: Day 365
description: A laser Doppler flowmeter (Periflux 5000 Perimed) will be used to measure skin blood flow in resting condition and during a local thermal hyperemia (LTH) test (temperature will be increased from 33 °C to 42 °C) for 35 min. The peak response during the LTH reflects vasodilatation caused by axonal reflex while the delayed plateau response of the LTH test is mainly dependent on the ability to produce nitric oxide to promote vasodilation.
measure: autonomic nervous system activity (measured by heart rate variability analysis)
time frame: Day 1
description: Physiological risk factors of VOC : electrocardiographic signals acquired by the polysomnographic machine will be extracted and the R-R intervals will be used for time domain spectral analyses to calculate several indices reflecting the activity of the autonomic nervous system activity. The ratio between the low frequency and the high frequency powers (LF/HF) will be used to characterize the autonomic imbalance.
measure: autonomic nervous system activity (measured by heart rate variability analysis)
time frame: Day 365
description: electrocardiographic signals acquired by the polysomnographic machine will be extracted and the R-R intervals will be used for time domain spectral analyses to calculate several indices reflecting the activity of the autonomic nervous system activity. The ratio between the low frequency and the high frequency powers (LF/HF) will be used to characterize the autonomic imbalance.
measure: Frequency of VOC
time frame: Day 365
description: Number of VOC requiring hospitalizations during the past year
arm group label: SS patients
arm group type: Active Comparator
description: Homozygous sickle cell patients
Each patient will undergo the following:
polysomnography and oxygen saturation exam
calculation of VOC rate within the two previous years
Blood samples
Physiological measurements
arm group label: SS patients apneic
arm group type: Experimental
description: Homozygous sickle cell patients after one year of continuous positive airway pressure treatment
Each patient will undergo the following:
polysomnography and oxygen saturation exam
calculation of VOC rate within the two previous years
Blood samples
Physiological measurements
intervention type: Diagnostic Test
intervention name: polysomnography and oxygen saturation exam
description: Measurement of the Apnea/hypopnea index (AHI) and oxygen saturation
arm group label: SS patients
arm group label: SS patients apneic
intervention type: Biological
intervention name: calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment
description: calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment
arm group label: SS patients
arm group label: SS patients apneic
intervention type: Biological
intervention name: Blood samples
description: Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers
arm group label: SS patients
arm group label: SS patients apneic
intervention type: Other
intervention name: Physiological measurements
description: Evaluation of microvascular reactivity and autonomic nervous system activity
arm group label: SS patients
arm group label: SS patients apneic
intervention type: Other
intervention name: Continuous Positive Airway Pressure
description: Continuous Positive Airway Pressure during 1 year
arm group label: SS patients apneic
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Anemia, Sickle Cell