<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/NCT04444778</url>
  </required_header>
  <id_info>
    <org_study_id>PI19/00875</org_study_id>
    <nct_id>NCT04444778</nct_id>
  </id_info>
  <brief_title>Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome.</brief_title>
  <official_title>Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome. Basic, Clinical and Therapeutically Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació d'investigació Sanitària de les Illes Balears</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació d'investigació Sanitària de les Illes Balears</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>
      Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To assess&#xD;
      the total or partial recovery of oxidative and inflammatory damage after recovering IH. 2) To&#xD;
      check whether the results obtained in vitro on the recovery of the damage according to the&#xD;
      form of manifestation of IH are validated in SAHS patients. 3) To determine if CPAP reduces&#xD;
      nighttime blood pressure and arterial stiffness depending on whether or not patients have a&#xD;
      non-dipping pattern of blood pressure and depending on the degree of correction of IH. 4) To&#xD;
      clarify whether residual nocturnal hypoxemia influences the recovery of oxidative and&#xD;
      inflammatory damage in patients. 5) To determine nasal and intestinal microbioma and the&#xD;
      effect of CPAP treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Randomized, parallel group, non-blinded, controlled clinical trial compared with&#xD;
      conventional treatment.&#xD;
&#xD;
      A. Protocol and intervention Patients with an AHI&gt;30 h-1 will be assigned, using a 1:1&#xD;
      randomization table, to lifestyle recommendations treatment or to lifestyle recommendations&#xD;
      plus nasal CPAP, for a period of 4 months. CPAP pressure will be titled with automatic using&#xD;
      an AutoSet II device, ResMed.&#xD;
&#xD;
      B. Sample size For the estimation of the sample size, previous data from our group were used.&#xD;
      In this case, in order to compare the effect of CPAP in a subgroup of patients with&#xD;
      well-controlled OSA and in another with residual hypoxemia; it would be necessary to&#xD;
      randomize a total of 85 patients with OSA.&#xD;
&#xD;
      C. Ethical considerations&#xD;
&#xD;
        -  Indication of CPAP treatment for the prevention of cardiovascular morbidity and&#xD;
           mortality in OSA patients without daytime sleepiness is not yet accepted.&#xD;
&#xD;
        -  Those patients with a urgent study indication for the diagnosis and treatment of&#xD;
           respiratory sleep disorders (professional drivers, respiratory failure or risk&#xD;
           professions) will be excluded from the project. In the other cases, the delay in&#xD;
           healthcare for the performance of Polysomnography and CPAP titration exceeds the&#xD;
           duration of the study, therefore that patients assigned to the control arm (conventional&#xD;
           treatment) will not be exposed to a higher risk than the general population.&#xD;
&#xD;
      D. Methods&#xD;
&#xD;
        -  Polysomnography. It will be used as a screening test previous the randomization of the&#xD;
           included patients. The exploration and its interpretation will be carried out following&#xD;
           the recommendations of the American Academy of Sleep Medicine. Based on the results of&#xD;
           this test, only those patients with an AHI will continue in the study when AHI &gt;30 h-1.&#xD;
           In these patients the determinations listed below will be carried out immediately before&#xD;
           randomization (visit 1), at 4 weeks (visit 2), 16 weeks (visit 4) of allocation to the&#xD;
           corresponding treatment group&#xD;
&#xD;
        -  Clinical data: The medication used and other associated diseases already diagnosed will&#xD;
           be recorded.&#xD;
&#xD;
        -  Vital signs: recording of blood pressure, by means of a conventional triple taking, and&#xD;
           heart rate.&#xD;
&#xD;
        -  Anthropometric characteristics: age and weight in basal conditions, the perimeter of the&#xD;
           neck and waist / hip index will be measured. The lean mass index will be determined&#xD;
           using a Bodystat 1500 impedance system (Bodystat Ltd, United Kingdom).&#xD;
&#xD;
        -  Questionnaires: Epworth Sleepiness Scale, generic health-related quality of life (SF-12&#xD;
           and EuroQoL) and daily physical activity (International Physical Activity Questionnaire&#xD;
           or iPAQ).&#xD;
&#xD;
        -  Laboratory findings: blood count, coagulation, creatinine, serum sodium and potassium;&#xD;
           glycated hemoglobin (HbA1c) and blood glucose and insulin levels in fasting, from these&#xD;
           values will determine the resistance and sensitivity to insulin using the HOMA and&#xD;
           QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides;&#xD;
           and troponin I, homocysteine, NT-pro BNP and highly sensitive C-reactive protein.&#xD;
&#xD;
        -  Blood venous samples. 20 mL of venous blood will be collected, storing the plasma&#xD;
           obtained at -80 ºC for subsequent determination of inflammatory markers (IL-1ß, IL-6,&#xD;
           IL-8, HIF 1- 'NF * + and TNF-a), oxidative stress (8-isoprostane), endothelial damage&#xD;
           (endothelin, angiotensin II, VCAM-1 and ICAM-1), of sympathetic activity (neuropeptide&#xD;
           Y, metanephrines) and appetite-regulating hormones (leptin and adiponectin).&#xD;
&#xD;
        -  Night pulse oximetry. To assess the existence of residual nocturnal hypoxemia.&#xD;
&#xD;
        -  Arterial stiffness. According to the recommendations by Sphygmo-Corsystem (version 7,&#xD;
           AtCor Medical, Sydney, Australia).&#xD;
&#xD;
        -  Study of the gut and pharyngeal microbiota by massive sequencing (next generation&#xD;
           sequencing) after PCR amplification of the 16S rRNA gene, paired-end sequencing with&#xD;
           Illumina technology (16S Amplicon and XT Nextera Metagenomic) and subsequent&#xD;
           metataxonomic analysis of the microbial populations.&#xD;
&#xD;
        -  Ambulatory blood pressure monitoring (ABPM) with Mortara's Ambulo 2400 ambulatory blood&#xD;
           pressure device.&#xD;
&#xD;
        -  In the patients assigned to the CPAP treatment arm, a count of the hours of use of the&#xD;
           CPAP will be carried out at each visit by directly reading the automatic counter of each&#xD;
           equipment.&#xD;
&#xD;
      Statistic analysis The data will be expressed as mean ± standard deviation, median&#xD;
      (interquartile range) or percentage, depending on their type and distribution. For comparison&#xD;
      between groups Student's t-test, the U-Mann-Whitney or the chi-square test will be used, as&#xD;
      appropriate. The relations between variables will be analyzed using Pearson's correlation and&#xD;
      multiple linear regression analysis. The effect of treatment will be evaluated using general&#xD;
      linear models and repeated measures analysis of variance, with multiple comparisons post-hoc&#xD;
      using the Bonferroni test. A multiple logistic regression model will be applied to determine&#xD;
      the related variables with a response to treatment. Values of p &lt;0.05 will be considered&#xD;
      statistically significant. The statistical study will be performed with the SPSS program&#xD;
      version 15.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in 8 isoprostane levels</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in 8 isoprostane levels between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota population diversity from stool samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota population diversity from nasopharyngeal samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota population abundance from stool samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota population abundance from nasopharyngeal samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota population color maps from stool samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in microbiota color maps from nasopharyngeal samples</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Augmentation index (%)</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in Augmentation index (%) between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Pulse wave velocity (m / sec) in arm</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in pulse wave velocity (m / sec) in arm between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form baseline in the plasmatic levels of biomarkers of inflammation</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in the plasmatic levels of interleukin (IL)-1beta, IL-6, IL-8, IL-10 and tumor necrosis factor-alpha, homocysteine, and C-reactive between the CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form baseline in the plasmatic levels of endothelin</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in the plasmatic levels of endothelin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) between the CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form baseline in the plasmatic levels of appetite-regulating hormones</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change in the plasmatic levels of leptin, adiponectin, and neuropeptide Y between the CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in number of patients with desaturation index &gt;3%</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in number of patients with desaturation index &gt;3% between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in aortic, systolic blood pressure central (mmHg)</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in systolic blood pressure central (mmHg) between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline aortic diastolic blood pressure central and (mmHg)</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in aortic diastolic blood pressure central (mm Hg) between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in peripheral systolic blood pressure (mmHg)</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in peripheral systolic blood pressure (mmHg) between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in peripheral diastolic blood pressure (mmHg)</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in peripheral diastolic blood pressure (mmHg)between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in number of patients with nocturnal blood pressure dipping</measure>
    <time_frame>4 months</time_frame>
    <description>To compare the change from baseline in number of patients with nocturnal blood pressure dipping between the patients allocated to CPAP group and the control group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>Continuous positive airway pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet and general life style recommendations plus continuous positive airway pressure (CPAP).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Diet and general life style recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CPAP</intervention_name>
    <description>Continuous positive airway pressure</description>
    <arm_group_label>Continuous positive airway pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases: patients with AHI &gt; 30&#xD;
&#xD;
          -  Controls: subjects with AHI &lt; 5 and Epworth &gt;10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epworth&gt;18&#xD;
&#xD;
          -  BMI&lt;40Kg/M2&#xD;
&#xD;
          -  Arterial Hypertension&#xD;
&#xD;
          -  Mellitus Diabetes&#xD;
&#xD;
          -  Cerebrovascular disease&#xD;
&#xD;
          -  Ischemic heart disease&#xD;
&#xD;
          -  Cardiac arrhythmia&#xD;
&#xD;
          -  Chronic cardiovascular diseases&#xD;
&#xD;
          -  Daytime Oxygen saturation&gt;95%&#xD;
&#xD;
          -  Risk professions (professional drivers)&#xD;
&#xD;
          -  Concomitant treatment with antihypertensives, statins, antidiabetics, beta-blockers or&#xD;
             systemics corticosteroids.&#xD;
&#xD;
          -  Pretreatment with CPAP.&#xD;
&#xD;
          -  Participation in another clinical trial thirty days prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alberto Alonso, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació d'investigació Sanitària de les Illes Balears</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alberto Alonso, Dr</last_name>
    <phone>+34871205050 (65517)</phone>
    <email>alberto.alonso@ssib.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma</city>
        <state>Balearic Islands</state>
        <zip>07006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Alonso</last_name>
      <phone>660914808</phone>
      <email>aaf_97@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llatzer</name>
      <address>
        <city>Palma</city>
        <state>Balearic Islands</state>
        <zip>07006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Maciá, Dr</last_name>
      <email>mariaasuncion.macia@hsll.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 23, 2021</last_update_submitted>
  <last_update_submitted_qc>May 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundació d'investigació Sanitària de les Illes Balears</investigator_affiliation>
    <investigator_full_name>Alberto Alonso Fernandez</investigator_full_name>
    <investigator_title>Médico adjunto servicio Neumología. Hospital Son Espases</investigator_title>
  </responsible_party>
  <keyword>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>Hypoxia</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/NCT04444778
org study id: PI19/00875
nct id: NCT04444778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To assess
      the total or partial recovery of oxidative and inflammatory damage after recovering IH. 2) To
      check whether the results obtained in vitro on the recovery of the damage according to the
      form of manifestation of IH are validated in SAHS patients. 3) To determine if CPAP reduces
      nighttime blood pressure and arterial stiffness depending on whether or not patients have a
      non-dipping pattern of blood pressure and depending on the degree of correction of IH. 4) To
      clarify whether residual nocturnal hypoxemia influences the recovery of oxidative and
      inflammatory damage in patients. 5) To determine nasal and intestinal microbioma and the
      effect of CPAP treatment
Design: Randomized, parallel group, non-blinded, controlled clinical trial compared with
      conventional treatment.

      A. Protocol and intervention Patients with an AHI>30 h-1 will be assigned, using a 1:1
      randomization table, to lifestyle recommendations treatment or to lifestyle recommendations
      plus nasal CPAP, for a period of 4 months. CPAP pressure will be titled with automatic using
      an AutoSet II device, ResMed.

      B. Sample size For the estimation of the sample size, previous data from our group were used.
      In this case, in order to compare the effect of CPAP in a subgroup of patients with
      well-controlled OSA and in another with residual hypoxemia; it would be necessary to
      randomize a total of 85 patients with OSA.

      C. Ethical considerations

        -  Indication of CPAP treatment for the prevention of cardiovascular morbidity and
           mortality in OSA patients without daytime sleepiness is not yet accepted.

        -  Those patients with a urgent study indication for the diagnosis and treatment of
           respiratory sleep disorders (professional drivers, respiratory failure or risk
           professions) will be excluded from the project. In the other cases, the delay in
           healthcare for the performance of Polysomnography and CPAP titration exceeds the
           duration of the study, therefore that patients assigned to the control arm (conventional
           treatment) will not be exposed to a higher risk than the general population.

      D. Methods

        -  Polysomnography. It will be used as a screening test previous the randomization of the
           included patients. The exploration and its interpretation will be carried out following
           the recommendations of the American Academy of Sleep Medicine. Based on the results of
           this test, only those patients with an AHI will continue in the study when AHI >30 h-1.
           In these patients the determinations listed below will be carried out immediately before
           randomization (visit 1), at 4 weeks (visit 2), 16 weeks (visit 4) of allocation to the
           corresponding treatment group

        -  Clinical data: The medication used and other associated diseases already diagnosed will
           be recorded.

        -  Vital signs: recording of blood pressure, by means of a conventional triple taking, and
           heart rate.

        -  Anthropometric characteristics: age and weight in basal conditions, the perimeter of the
           neck and waist / hip index will be measured. The lean mass index will be determined
           using a Bodystat 1500 impedance system (Bodystat Ltd, United Kingdom).

        -  Questionnaires: Epworth Sleepiness Scale, generic health-related quality of life (SF-12
           and EuroQoL) and daily physical activity (International Physical Activity Questionnaire
           or iPAQ).

        -  Laboratory findings: blood count, coagulation, creatinine, serum sodium and potassium;
           glycated hemoglobin (HbA1c) and blood glucose and insulin levels in fasting, from these
           values will determine the resistance and sensitivity to insulin using the HOMA and
           QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides;
           and troponin I, homocysteine, NT-pro BNP and highly sensitive C-reactive protein.

        -  Blood venous samples. 20 mL of venous blood will be collected, storing the plasma
           obtained at -80 ºC for subsequent determination of inflammatory markers (IL-1ß, IL-6,
           IL-8, HIF 1- 'NF * + and TNF-a), oxidative stress (8-isoprostane), endothelial damage
           (endothelin, angiotensin II, VCAM-1 and ICAM-1), of sympathetic activity (neuropeptide
           Y, metanephrines) and appetite-regulating hormones (leptin and adiponectin).

        -  Night pulse oximetry. To assess the existence of residual nocturnal hypoxemia.

        -  Arterial stiffness. According to the recommendations by Sphygmo-Corsystem (version 7,
           AtCor Medical, Sydney, Australia).

        -  Study of the gut and pharyngeal microbiota by massive sequencing (next generation
           sequencing) after PCR amplification of the 16S rRNA gene, paired-end sequencing with
           Illumina technology (16S Amplicon and XT Nextera Metagenomic) and subsequent
           metataxonomic analysis of the microbial populations.

        -  Ambulatory blood pressure monitoring (ABPM) with Mortara's Ambulo 2400 ambulatory blood
           pressure device.

        -  In the patients assigned to the CPAP treatment arm, a count of the hours of use of the
           CPAP will be carried out at each visit by directly reading the automatic counter of each
           equipment.

      Statistic analysis The data will be expressed as mean ± standard deviation, median
      (interquartile range) or percentage, depending on their type and distribution. For comparison
      between groups Student's t-test, the U-Mann-Whitney or the chi-square test will be used, as
      appropriate. The relations between variables will be analyzed using Pearson's correlation and
      multiple linear regression analysis. The effect of treatment will be evaluated using general
      linear models and repeated measures analysis of variance, with multiple comparisons post-hoc
      using the Bonferroni test. A multiple logistic regression model will be applied to determine
      the related variables with a response to treatment. Values of p <0.05 will be considered
      statistically significant. The statistical study will be performed with the SPSS program
      version 15.0.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in 8 isoprostane levels
time frame: 4 months
description: To compare the change in 8 isoprostane levels between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota population diversity from stool samples
time frame: 4 months
description: To compare the change in in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota population diversity from nasopharyngeal samples
time frame: 4 months
description: To compare the change in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota population abundance from stool samples
time frame: 4 months
description: To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota population abundance from nasopharyngeal samples
time frame: 4 months
description: To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota population color maps from stool samples
time frame: 4 months
description: To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in microbiota color maps from nasopharyngeal samples
time frame: 4 months
description: To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
measure: Change from baseline in Augmentation index (%)
time frame: 4 months
description: To compare the change in Augmentation index (%) between the patients allocated to CPAP group and the control group
measure: Change from baseline in Pulse wave velocity (m / sec) in arm
time frame: 4 months
description: To compare the change from baseline in pulse wave velocity (m / sec) in arm between the patients allocated to CPAP group and the control group
measure: Change form baseline in the plasmatic levels of biomarkers of inflammation
time frame: 4 months
description: To compare the change in the plasmatic levels of interleukin (IL)-1beta, IL-6, IL-8, IL-10 and tumor necrosis factor-alpha, homocysteine, and C-reactive between the CPAP group and the control group
measure: Change form baseline in the plasmatic levels of endothelin
time frame: 4 months
description: To compare the change in the plasmatic levels of endothelin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) between the CPAP group and the control group
measure: Change form baseline in the plasmatic levels of appetite-regulating hormones
time frame: 4 months
description: To compare the change in the plasmatic levels of leptin, adiponectin, and neuropeptide Y between the CPAP group and the control group
measure: Change from baseline in number of patients with desaturation index >3%
time frame: 4 months
description: To compare the change from baseline in number of patients with desaturation index >3% between the patients allocated to CPAP group and the control group
measure: Change from baseline in aortic, systolic blood pressure central (mmHg)
time frame: 4 months
description: To compare the change from baseline in systolic blood pressure central (mmHg) between the patients allocated to CPAP group and the control group
measure: Change from baseline aortic diastolic blood pressure central and (mmHg)
time frame: 4 months
description: To compare the change from baseline in aortic diastolic blood pressure central (mm Hg) between the patients allocated to CPAP group and the control group
measure: Change from baseline in peripheral systolic blood pressure (mmHg)
time frame: 4 months
description: To compare the change from baseline in peripheral systolic blood pressure (mmHg) between the patients allocated to CPAP group and the control group
measure: Change from baseline in peripheral diastolic blood pressure (mmHg)
time frame: 4 months
description: To compare the change from baseline in peripheral diastolic blood pressure (mmHg)between the patients allocated to CPAP group and the control group
measure: Change from baseline in number of patients with nocturnal blood pressure dipping
time frame: 4 months
description: To compare the change from baseline in number of patients with nocturnal blood pressure dipping between the patients allocated to CPAP group and the control group
arm group label: Continuous positive airway pressure
arm group type: Active Comparator
description: Diet and general life style recommendations plus continuous positive airway pressure (CPAP).
arm group label: Conservative treatment
arm group type: No Intervention
description: Diet and general life style recommendations.
intervention type: Device
intervention name: CPAP
description: Continuous positive airway pressure
arm group label: Continuous positive airway pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alberto Alonso, Dr
role: Principal Investigator
affiliation: Fundació d'investigació Sanitària de les Illes Balears
last name: Alberto Alonso, Dr
phone: +34871205050 (65517)
email: alberto.alonso@ssib.es
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundació d'investigació Sanitària de les Illes Balears
investigator full name: Alberto Alonso Fernandez
investigator title: Médico adjunto servicio Neumología. Hospital Son Espases
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypoxia