xml: <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/NCT05986487</url>
    </required_header>
    <id_info>
      <org_study_id>PMP22/00030</org_study_id>
      <nct_id>NCT05986487</nct_id>
    </id_info>
    <brief_title>Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project</brief_title>
    <official_title>Impact of Sleep-Disordered Breathing Management in Systemic Hypertension Control: METASLEEP Project</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sociedad Española de Neumología y Cirugía Torácica</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Instituto de Salud Carlos III</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sociedad Española de Neumología y Cirugía Torácica</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>
        Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading&#xD;
        modifiable contributor to cardiovascular disease and death. Our society has already&#xD;
        identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of&#xD;
        healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly&#xD;
        supported by the extensively available scientific evidence. Targeting sleep is considered the&#xD;
        new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages&#xD;
        consideration of including sleep disturbances in the top 10 potentially modifiable&#xD;
        cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with&#xD;
        hypertension. The personalized management of hypertension is challenging due to; i) the&#xD;
        misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of&#xD;
        adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical&#xD;
        need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk&#xD;
        factor for hypertension. Importantly, we already made the seminal observations showing that&#xD;
        the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive&#xD;
        phenotypes with the highest mortality risk. Given the need for novel strategies to treat&#xD;
        hypertension and, supported by our data, we propose to study and treat sleep-disordered&#xD;
        breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art&#xD;
        providing a new paradigm for the accurate hypertension classification and treatment. This&#xD;
        project will open up a new avenue on the therapeutic potential of the management of&#xD;
        sleep-disordered breathing in hypertension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This project aims to implement a new hypertension management system, which will include the&#xD;
        monitoring and treatment of respiratory disorders during sleep. This new precision&#xD;
        medicine-based management will be carried out in the Primary Care setting and will improve&#xD;
        blood pressure control, the main risk factor for the leading cause of death worldwide:&#xD;
        cardiovascular diseases.&#xD;
  &#xD;
        The current model for managing patients with essential hypertension is based on deciding when&#xD;
        to treat with measures that go beyond dietary and lifestyle interventions. Once it is decided&#xD;
        to treat the patient pharmacologically, the ideal drug is decided and during follow-up&#xD;
        whether it is necessary to change the treatment or not. This entire process is usually&#xD;
        carried out by the Primary Care doctors. The hypertension specialist is usually reserved for&#xD;
        difficult-to-control cases or patients with resistant hypertension. In the current model&#xD;
        there is little communication between the different levels of care. In addition, the study of&#xD;
        the SDB is carried out completely independently of this process. The METASLEEP project aims&#xD;
        to change this work dynamic. The creation of the METASLEEP PC-node centralizes care for&#xD;
        patients with hypertension in the Primary Care team (physician and nurse). The PC-node will&#xD;
        evaluate the patient comprehensively, incorporating 24-hour ambulatory blood pressure&#xD;
        monitoring as well as a sleep study. There will be coordination with the hypertension&#xD;
        specialist for the management of complex cases and with the sleep unit specialist to support&#xD;
        therapeutic decisions or management of patients with complex sleep apnea. Moreover, our&#xD;
        project aims to incorporate the precision medicine techniques, such as the HIPARCO-score in&#xD;
        the clinical management of hypertensive patients. Furthermore, we aim to identify the best&#xD;
        option that guarantees the best control in different clinical situations, with the greatest&#xD;
        anticipation and with the fewest side effects, as well as with the greatest additional&#xD;
        benefits and, finally, when to modify the treatment.&#xD;
  &#xD;
        The METASLEEP project aims to contribute to the development of personalized medicine tools by&#xD;
        identifying the molecular profile that enables to develop a non-invasive model with clinical&#xD;
        utility. This model will contribute to the characterization of the patient that is vulnerable&#xD;
        to the deleterious effects of OSA and who would benefit from OSA treatment to improve&#xD;
        cardiovascular morbidity. The availability of an instrument based on a biomarker profile for&#xD;
        risk stratification will help the physician to make therapeutic decisions in individuals with&#xD;
        OSA and hypertension, contributing to the change of the current clinical management&#xD;
        guidelines. Likewise, molecular tools can be developed to identify the profile of the patient&#xD;
        that positively respond to CPAP treatment (in terms of blood pressure decrease). Finally, we&#xD;
        will obtain data that will evaluate the economic impact of the METASLEEP project. This&#xD;
        cost-effectiveness analysis will be carried out from the perspectives of both, the SNS and&#xD;
        the social perspective. Importantly, we have planned a specific objective to define and&#xD;
        calculate quantitatively, qualitative and cost-effectively the METASLEEP project, compared to&#xD;
        the conventional current procedure.&#xD;
  &#xD;
        The overall objective of the METASLEEP project is to establish a new paradigm in the&#xD;
        treatment of hypertension through the management of sleep disordered breathing (SDB).&#xD;
  &#xD;
        The specific objectives, are the following:&#xD;
  &#xD;
          1. To implement the management of hypertension based on the presence of nocturnal&#xD;
             hypertension and SDB (METASLEEP model).&#xD;
  &#xD;
          2. To depict a singular cluster of circulating miRNAs (METASLEEP-score) in patients with&#xD;
             nocturnal hypertension and SDB.&#xD;
  &#xD;
          3. To characterize highly responder patients that would benefit from SDB treatment in terms&#xD;
             of blood pressure control.&#xD;
  &#xD;
          4. To implement in the clinical practice the use of the HIPARCO-score technology for the&#xD;
             management of resistant hypertension.&#xD;
  &#xD;
          5. To evaluate the feasibility and acceptability of the METASLEEP model for the&#xD;
             comprehensive clinical management of hypertension based in the management of SDB.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in nocturnal blood pressure</measure>
      <time_frame>At 6 and 18 months</time_frame>
      <description>Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinic phenotype characterization</measure>
      <time_frame>6 months</time_frame>
      <description>Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes induced by exosomes</measure>
      <time_frame>6 months</time_frame>
      <description>Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)</measure>
      <time_frame>2 years</time_frame>
      <description>Analyse mRNA to validate de HIPARCO score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creation of a predictive tool (like HIPARCO-Score) for women</measure>
      <time_frame>2 years</time_frame>
      <description>Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.</measure>
      <time_frame>After 18 months of follow-up</time_frame>
      <description>Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validation of the METASLEEP score</measure>
      <time_frame>2 years</time_frame>
      <description>Identify specific miRNAs signature that would have the capability to identify patients with nocturnal hypertension, likely to exhibit a favorable blood pressure response to SDB treatment for the blood pressure control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CPAP compliance at 6 and 18 months</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Objective data to be downloaded from the CPAP device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction at 6 and 18 months</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Visual analog scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Epworth Sleepiness Scale (ESS)</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Changes in Epworth Sleepiness Scale (ESS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Quality of life: Test EuroQol</measure>
      <time_frame>6 and 18 months</time_frame>
      <description>Changes in Quality of life: Test EuroQol</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1523</enrollment>
    <condition>Hypertension</condition>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA</arm_group_label>
      <description>Patients with nocturnal hypertension and/or non-dipper pattern who undergo a sleep test, obtaining the diagnosis of obstructive sleep apnea, will be treated following the clinical practice standards.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with nocturnal hypertension and/or non-dipper pattern and without OSA</arm_group_label>
      <description>Patients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CPAP or usual practice</intervention_name>
      <description>CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.</description>
      <arm_group_label>Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Monitoring and intervention in follow-up</intervention_name>
      <description>Each participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics. Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep. This intervention will help the patient to improve in different aspects of their health.</description>
      <arm_group_label>Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA</arm_group_label>
      <arm_group_label>Patients with nocturnal hypertension and/or non-dipper pattern and without OSA</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        -  2 tubes EDTA (6 ml)&#xD;
  &#xD;
          -  2 tubes with separating gel for serum (6 ml)&#xD;
  &#xD;
          -  1 tempus RNA tube (2,5 ml)&#xD;
  &#xD;
          -  1 tube for urine and urine sediment (3 ml)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients atttending to their primary care center for the control of their arterial&#xD;
          hypertension.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with arterial hypertension who visit their primary care physician in one of&#xD;
               the participating primary care centers.&#xD;
  &#xD;
            -  Signature of the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psycho-physical inability to complete questionnaires.&#xD;
  &#xD;
            -  Patients with very limiting chronic disease.&#xD;
  &#xD;
            -  Previous diagnosis of OSA or any other sleeping disorder&#xD;
  &#xD;
            -  Active treatment with CPAP.&#xD;
  &#xD;
            -  Fixed night shift worker.&#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>Ferran Barbé Illa, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Spanish Respiratory Society (SEPAR)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ferran Barbé Illa, MD</last_name>
      <phone>+34 973705372</phone>
      <email>febarbe.lleida.ics@gencat.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Manuel Sánchez de la Torre, PhD</last_name>
      <phone>+34 973702959</phone>
      <email>manuel.sanchez@udl.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitari Arnau de Vilanova</name>
        <address>
          <city>Lleida</city>
          <zip>25198</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Ferran Barbé Illa, MD</last_name>
        <phone>+34 973705372</phone>
        <email>febarbe.lleida.ics@gencat.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sociedad Española de Neumología y Cirugía Torácica</investigator_affiliation>
      <investigator_full_name>Ferran Barbe</investigator_full_name>
      <investigator_title>Chair Respiratory Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986487
  org study id: PMP22/00030
  nct id: NCT05986487
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading
        modifiable contributor to cardiovascular disease and death. Our society has already
        identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of
        healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly
        supported by the extensively available scientific evidence. Targeting sleep is considered the
        new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages
        consideration of including sleep disturbances in the top 10 potentially modifiable
        cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with
        hypertension. The personalized management of hypertension is challenging due to; i) the
        misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of
        adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical
        need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk
        factor for hypertension. Importantly, we already made the seminal observations showing that
        the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive
        phenotypes with the highest mortality risk. Given the need for novel strategies to treat
        hypertension and, supported by our data, we propose to study and treat sleep-disordered
        breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art
        providing a new paradigm for the accurate hypertension classification and treatment. This
        project will open up a new avenue on the therapeutic potential of the management of
        sleep-disordered breathing in hypertension.
  This project aims to implement a new hypertension management system, which will include the
        monitoring and treatment of respiratory disorders during sleep. This new precision
        medicine-based management will be carried out in the Primary Care setting and will improve
        blood pressure control, the main risk factor for the leading cause of death worldwide:
        cardiovascular diseases.
  
        The current model for managing patients with essential hypertension is based on deciding when
        to treat with measures that go beyond dietary and lifestyle interventions. Once it is decided
        to treat the patient pharmacologically, the ideal drug is decided and during follow-up
        whether it is necessary to change the treatment or not. This entire process is usually
        carried out by the Primary Care doctors. The hypertension specialist is usually reserved for
        difficult-to-control cases or patients with resistant hypertension. In the current model
        there is little communication between the different levels of care. In addition, the study of
        the SDB is carried out completely independently of this process. The METASLEEP project aims
        to change this work dynamic. The creation of the METASLEEP PC-node centralizes care for
        patients with hypertension in the Primary Care team (physician and nurse). The PC-node will
        evaluate the patient comprehensively, incorporating 24-hour ambulatory blood pressure
        monitoring as well as a sleep study. There will be coordination with the hypertension
        specialist for the management of complex cases and with the sleep unit specialist to support
        therapeutic decisions or management of patients with complex sleep apnea. Moreover, our
        project aims to incorporate the precision medicine techniques, such as the HIPARCO-score in
        the clinical management of hypertensive patients. Furthermore, we aim to identify the best
        option that guarantees the best control in different clinical situations, with the greatest
        anticipation and with the fewest side effects, as well as with the greatest additional
        benefits and, finally, when to modify the treatment.
  
        The METASLEEP project aims to contribute to the development of personalized medicine tools by
        identifying the molecular profile that enables to develop a non-invasive model with clinical
        utility. This model will contribute to the characterization of the patient that is vulnerable
        to the deleterious effects of OSA and who would benefit from OSA treatment to improve
        cardiovascular morbidity. The availability of an instrument based on a biomarker profile for
        risk stratification will help the physician to make therapeutic decisions in individuals with
        OSA and hypertension, contributing to the change of the current clinical management
        guidelines. Likewise, molecular tools can be developed to identify the profile of the patient
        that positively respond to CPAP treatment (in terms of blood pressure decrease). Finally, we
        will obtain data that will evaluate the economic impact of the METASLEEP project. This
        cost-effectiveness analysis will be carried out from the perspectives of both, the SNS and
        the social perspective. Importantly, we have planned a specific objective to define and
        calculate quantitatively, qualitative and cost-effectively the METASLEEP project, compared to
        the conventional current procedure.
  
        The overall objective of the METASLEEP project is to establish a new paradigm in the
        treatment of hypertension through the management of sleep disordered breathing (SDB).
  
        The specific objectives, are the following:
  
          1. To implement the management of hypertension based on the presence of nocturnal
             hypertension and SDB (METASLEEP model).
  
          2. To depict a singular cluster of circulating miRNAs (METASLEEP-score) in patients with
             nocturnal hypertension and SDB.
  
          3. To characterize highly responder patients that would benefit from SDB treatment in terms
             of blood pressure control.
  
          4. To implement in the clinical practice the use of the HIPARCO-score technology for the
             management of resistant hypertension.
  
          5. To evaluate the feasibility and acceptability of the METASLEEP model for the
             comprehensive clinical management of hypertension based in the management of SDB.
  observational model: Cohort
  time perspective: Prospective
  measure: Changes in nocturnal blood pressure
  time frame: At 6 and 18 months
  description: Change in nocturnal blood pressure at 6 and 18 months with respect to baseline (mean night-time)
  measure: Identification of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
  time frame: 6 and 18 months
  description: Identification a specific singular cluster of circulating miRNAs in patients with nocturnal hypertension and sleep disordered breathing.
  measure: Epigenetic, proteomic and metabolomic/lipidomic phenotype characterization
  time frame: 6 and 18 months
  description: Characterization of the epigenetic, proteomic and metabolomic/lipidomic phenotype of hypertensive highly responders to CPAP treatment
  measure: Clinic phenotype characterization
  time frame: 6 months
  description: Characterization of the clinic phenotype of hypertensive highly responders to CPAP treatment
  measure: Changes induced by exosomes
  time frame: 6 months
  description: Changes in morphological, functional and molecular promoted by exosomes isolated from selected patients.
  measure: Validation the HIPARCO-Score tool in an independent cohort, men with resistant hypertension, OSA and CPAP compliance (≥4h/night)
  time frame: 2 years
  description: Analyse mRNA to validate de HIPARCO score
  measure: Creation of a predictive tool (like HIPARCO-Score) for women
  time frame: 2 years
  description: Identify a plasma miRNA profile that predicts blood pressure response to CPAP treatment.
  measure: Cost-Effectiveness analyses between study groups and to compare the cost of health care utilization between two year before and after the starting of the study related to the study groups.
  time frame: After 18 months of follow-up
  description: Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained
  measure: Validation of the METASLEEP score
  time frame: 2 years
  description: Identify specific miRNAs signature that would have the capability to identify patients with nocturnal hypertension, likely to exhibit a favorable blood pressure response to SDB treatment for the blood pressure control.
  measure: CPAP compliance at 6 and 18 months
  time frame: 6 and 18 months
  description: Objective data to be downloaded from the CPAP device
  measure: Satisfaction at 6 and 18 months
  time frame: 6 and 18 months
  description: Visual analog scale
  measure: Changes in Epworth Sleepiness Scale (ESS)
  time frame: 6 and 18 months
  description: Changes in Epworth Sleepiness Scale (ESS)
  measure: Changes in Quality of life: Test EuroQol
  time frame: 6 and 18 months
  description: Changes in Quality of life: Test EuroQol
  arm group label: Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
  description: Patients with nocturnal hypertension and/or non-dipper pattern who undergo a sleep test, obtaining the diagnosis of obstructive sleep apnea, will be treated following the clinical practice standards.
  arm group label: Patients with nocturnal hypertension and/or non-dipper pattern and without OSA
  description: Patients with nocturnal hypertension and/or non-dipper pattern undergoing a sleep test, the result of which is negative for obstructive sleep apnea disease.
  intervention type: Device
  intervention name: CPAP or usual practice
  description: CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.
  arm group label: Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
  intervention type: Device
  intervention name: Monitoring and intervention in follow-up
  description: Each participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics. Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep. This intervention will help the patient to improve in different aspects of their health.
  arm group label: Patients with nocturnal hypertension and/or non-dipper pattern and diagnosed with OSA
  arm group label: Patients with nocturnal hypertension and/or non-dipper pattern and without OSA
  -  2 tubes EDTA (6 ml)
  
          -  2 tubes with separating gel for serum (6 ml)
  
          -  1 tempus RNA tube (2,5 ml)
  
          -  1 tube for urine and urine sediment (3 ml)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ferran Barbé Illa, MD
  role: Principal Investigator
  affiliation: Spanish Respiratory Society (SEPAR)
  last name: Ferran Barbé Illa, MD
  phone: +34 973705372
  email: febarbe.lleida.ics@gencat.cat
  last name: Manuel Sánchez de la Torre, PhD
  phone: +34 973702959
  email: manuel.sanchez@udl.cat
  facility: 
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Sociedad Española de Neumología y Cirugía Torácica
  investigator full name: Ferran Barbe
  investigator title: Chair Respiratory Medicine
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Hypertension
  sharing ipd: No