<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/NCT04413747</url>
  </required_header>
  <id_info>
    <org_study_id>2020_COVID-19_YOGA</org_study_id>
    <nct_id>NCT04413747</nct_id>
  </id_info>
  <brief_title>Yoga Pranayama Adjuvant to Treat Burden COVID-19</brief_title>
  <acronym>YOCO</acronym>
  <official_title>Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Ricerca e Sviluppo S.R.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yoga Experience Association,Cervia (Ra), Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>EJTN GEIE, Brussellese, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Halnet Srl, Faenza (Ra), Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Ricerca e Sviluppo S.R.L.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs&#xD;
      mainly from immunological behavior or by suicide after healing . In both cases, the causal&#xD;
      link is coronavirus within the host response. The rationale of use of deep yoga breathing as&#xD;
      adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the&#xD;
      vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity&#xD;
      of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory&#xD;
      cytokines overproduction and contextual lowering of the sympathetic stress response as a&#xD;
      first cause of sleep and late mental disorders which can increase the annual suicide rate. An&#xD;
      easily breathing medical Yoga protocol has been developed to test a cost-effective care&#xD;
      provision, training, contact tracing and mass efficacy testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, pandemic&#xD;
      threatens patients, societies and healthcare systems around the world. Morbidity and&#xD;
      lethality have a direct link with the early vicious circles triggered by an acute&#xD;
      microcirculation endotheliopathy, a correlated coagulopathy, up to late hypoxic damage of&#xD;
      multi organ tissue The host immunity determines the progress of the disease , its lethality&#xD;
      and the need of care intensity. The clinical course of the infection consist of three stage&#xD;
      of which only the third -which intervenes in a low incidence of patients - need of&#xD;
      hospitalization for severe hyperinflammatory syndrome including acute respiratory failure,&#xD;
      while first and the second or moderate pulmonary involvement, might manage and monitoring&#xD;
      within a homecare program during quarantine. Actually, the rough mortality in Italy is - at&#xD;
      the current date - 7.6 % with an expected death of 0.004 of the whole population. The late&#xD;
      lethality - still little known - from COVID-19 is to be correlated with mental disorders from&#xD;
      stress response emerging from the first three COVID-19's stages and which result in a&#xD;
      significant increase in suicides that is estimated at 30% more than expected of 7.4 deaths&#xD;
      for 100,000 residents. This estimate can be considered as stage 4 of the disease or post&#xD;
      COVID-19 mortality. In this scenario, mortality of COVID-19 is by intensity response of &quot;the&#xD;
      host &quot; and in the meantime, a cutoff for homecare, hospitalization and time-related stress&#xD;
      disease. Lines of evidence reports that direct-indirect stimulation of vagus nerve bring to&#xD;
      the modulating of pro-inflammatory cytokines with effective systemic anti-inflammatory effect&#xD;
      and has shown antidepressant effects in chronic treatment resistant depression. Because the&#xD;
      vagus nerve is linked to brain regions important in anxiety regulation (locus coeruleus,&#xD;
      orbitofrontal cortex, insula, hippocampus and amygdala), this pathway is involved in&#xD;
      perceiving various somatic and cognitive symptoms that characterize anxiety and mental&#xD;
      disorder disorders. On the basis of all these reasoning we plan to introduce a medical&#xD;
      based-yoga deep breathing for activation of vagus nerve by scalene and sternocleidomastoid&#xD;
      muscles function during breathing, as an adjuvant of care of the 1-2 and 4 stages of the&#xD;
      COVID-19 disease to counteract the cumulative incidence of mortality and better outcome.&#xD;
      Medical yoga protocol has been developed and designed to test a cost-effective care&#xD;
      provision, training, contact tracing and mass efficacy testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective cohort study based on clinical assessment. Model- based adjusted outcome via hierarchical comparison of control curves using COVID19 national epidemic data with cyber layer algorithm of population</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>identifier number (ID) without any refer to clinical assessment or to patients</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months.</time_frame>
    <description>COVID-19's Patients mortality all cause: incidence proportion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality-suicide</measure>
    <time_frame>12 months.</time_frame>
    <description>COVID-19's Patients suicide: incidence proportion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of hospitalization for respiratory failure of COVID-19's Patients-</measure>
    <time_frame>1 months.</time_frame>
    <description>In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of al home professional psychiatric-psychological interventions for mental disorder.</measure>
    <time_frame>12 months.</time_frame>
    <description>Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).</measure>
    <time_frame>12 months.</time_frame>
    <description>Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff &gt; 29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).</measure>
    <time_frame>12 months.</time_frame>
    <description>Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff &gt; 8.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Cytokine Storm</condition>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Yoga-based breathing support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three daily yoga pranayama breathing cycles within existing home-care provision of Covid19's patients (protocols shared dated 27 March 2020 by Italian Society of Infectious and Tropical Diseases - Italian General Practitioners Physician - Italian Society of General Medicine, Italy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>morning Yoga-based breathing support</intervention_name>
    <description>Low and deep inspiration and phonetic syllable OM laryngeal vibration ( OM technique) as expiratory exercises, sitting in easy pose. The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Bhramari pranayama n° of 5 RAc.</description>
    <arm_group_label>Yoga-based breathing support</arm_group_label>
    <other_name>First procedure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>pre_lunch Yoga-based breathing support</intervention_name>
    <description>Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Surya Bheda pranayama n° of 5 RAc.</description>
    <arm_group_label>Yoga-based breathing support</arm_group_label>
    <other_name>Second procedure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>pre_dinner Yoga-based breathing support</intervention_name>
    <description>Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Nadi Shodhana pranayama n° of 5 RAc.</description>
    <arm_group_label>Yoga-based breathing support</arm_group_label>
    <other_name>Third procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial;&#xD;
&#xD;
          -  Male or Female, aged 18 years or above;&#xD;
&#xD;
          -  Diagnosed COVID-19's infection;&#xD;
&#xD;
          -  Informed consent;&#xD;
&#xD;
          -  Having been diagnosed in the last 1 week;&#xD;
&#xD;
          -  In the Investigator's opinion, is able and willing to comply with all trial&#xD;
             requirements;&#xD;
&#xD;
          -  Willing to allow his or her General Practitioner and consultant, if appropriate, to be&#xD;
             notified of participation in the trial;&#xD;
&#xD;
          -  Patients who continue to be followed at home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The participant may not enter the trial if ANY of the following apply:&#xD;
&#xD;
          -  No informed consent;&#xD;
&#xD;
          -  Participant is not willing and able to give informed consent for participation in the&#xD;
             trial;&#xD;
&#xD;
          -  Female participant who is pregnant, lactating or planning pregnancy during the course&#xD;
             of the trial;&#xD;
&#xD;
          -  Hospitalization patients;&#xD;
&#xD;
          -  Having a serious cognitive impairment;&#xD;
&#xD;
          -  Having serious hearing and vision problems;&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the trial, or may&#xD;
             influence the result of the trial, or the participant's ability to participate in the&#xD;
             trial;&#xD;
&#xD;
          -  Participants who have participated in another research trial involving an&#xD;
             investigational product in the past 12 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nagarathna Raghuram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>HR Nagendra., Eng</last_name>
    <role>Study Chair</role>
    <affiliation>Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Donatella Barbagallo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yoga Experience Association,Cervia (Ra), Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Enrico Ricci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yoga Experience Association,Cervia (Ra), Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morena Gaddoni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Luisa Vitobello</last_name>
    <role>Study Director</role>
    <affiliation>EJTN GEIE, Brussellese, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luca Ghetti, Eng.</last_name>
    <role>Study Director</role>
    <affiliation>Halnet Srl</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabio Zucchetta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giorgio Noera, MD, PhD</last_name>
    <phone>+393358294727</phone>
    <email>presidenza@healthricercaesviluppo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Boris Bazzani, ERYT</last_name>
    <phone>+393384841931</phone>
    <email>amministrazione@fbiteam.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ambulatorio Telemedicina Giardino St Lucia</name>
      <address>
        <city>Massa Lombarda</city>
        <state>Ravenna</state>
        <zip>48024</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Morena Gaddoni</last_name>
      <phone>+39054581871</phone>
      <email>direzione@giardinostlucia.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Wenham C, Smith J, Morgan R; Gender and COVID-19 Working Group. COVID-19: the gendered impacts of the outbreak. Lancet. 2020 Mar 14;395(10227):846-848. doi: 10.1016/S0140-6736(20)30526-2. Epub 2020 Mar 6. No abstract available.</citation>
    <PMID>32151325</PMID>
  </reference>
  <reference>
    <citation>Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5. Erratum In: Crit Care. 2017 Jul 13;21(1):187.</citation>
    <PMID>28179016</PMID>
  </reference>
  <reference>
    <citation>Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.</citation>
    <PMID>10839541</PMID>
  </reference>
  <reference>
    <citation>Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. Epub 2016 Jul 5.</citation>
    <PMID>27382171</PMID>
  </reference>
  <reference>
    <citation>Thayer JF, Sternberg EM. Neural aspects of immunomodulation: focus on the vagus nerve. Brain Behav Immun. 2010 Nov;24(8):1223-8. doi: 10.1016/j.bbi.2010.07.247. Epub 2010 Jul 30.</citation>
    <PMID>20674737</PMID>
  </reference>
  <reference>
    <citation>Lv H, Zhao YH, Chen JG, Wang DY, Chen H. Vagus Nerve Stimulation for Depression: A Systematic Review. Front Psychol. 2019 Jan 31;10:64. doi: 10.3389/fpsyg.2019.00064. eCollection 2019.</citation>
    <PMID>30766497</PMID>
  </reference>
  <reference>
    <citation>O'Reardon JP, Cristancho P, Peshek AD. Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the Brainstem and Beyond. Psychiatry (Edgmont). 2006 May;3(5):54-63.</citation>
    <PMID>21103178</PMID>
  </reference>
  <reference>
    <citation>Jordana J, Trivino-Salazar JC. Where are the ECDC and the EU-wide responses in the COVID-19 pandemic? Lancet. 2020 May 23;395(10237):1611-1612. doi: 10.1016/S0140-6736(20)31132-6. Epub 2020 May 13. No abstract available.</citation>
    <PMID>32410757</PMID>
  </reference>
  <reference>
    <citation>Zhu S, Wu Y, Zhu CY, Hong WC, Yu ZX, Chen ZK, Chen ZL, Jiang DG, Wang YG. The immediate mental health impacts of the COVID-19 pandemic among people with or without quarantine managements. Brain Behav Immun. 2020 Jul;87:56-58. doi: 10.1016/j.bbi.2020.04.045. Epub 2020 Apr 18.</citation>
    <PMID>32315758</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>CYTOKINE STORM</keyword>
  <keyword>MEDICAL YOGA PRANAYAMA</keyword>
  <keyword>VAGUS NERVE STIMOLATION</keyword>
  <keyword>MENTAL DISORDER</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Cytokine Release Syndrome</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>18 months</ipd_time_frame>
    <ipd_access_criteria>ID (nikname ) and password</ipd_access_criteria>
    <ipd_url>https://ifc.cnr.it</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>guest_1</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://giardinostlucia.it</doc_url>
    </study_doc>
    <study_doc>
      <doc_id>guest_2</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://giardinostlucia.it</doc_url>
    </study_doc>
    <study_doc>
      <doc_id>guest_3</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>http://giardinostlucia.it</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04413747
org study id: 2020_COVID-19_YOGA
nct id: NCT04413747
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs
      mainly from immunological behavior or by suicide after healing . In both cases, the causal
      link is coronavirus within the host response. The rationale of use of deep yoga breathing as
      adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the
      vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity
      of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory
      cytokines overproduction and contextual lowering of the sympathetic stress response as a
      first cause of sleep and late mental disorders which can increase the annual suicide rate. An
      easily breathing medical Yoga protocol has been developed to test a cost-effective care
      provision, training, contact tracing and mass efficacy testing.
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, pandemic
      threatens patients, societies and healthcare systems around the world. Morbidity and
      lethality have a direct link with the early vicious circles triggered by an acute
      microcirculation endotheliopathy, a correlated coagulopathy, up to late hypoxic damage of
      multi organ tissue The host immunity determines the progress of the disease , its lethality
      and the need of care intensity. The clinical course of the infection consist of three stage
      of which only the third -which intervenes in a low incidence of patients - need of
      hospitalization for severe hyperinflammatory syndrome including acute respiratory failure,
      while first and the second or moderate pulmonary involvement, might manage and monitoring
      within a homecare program during quarantine. Actually, the rough mortality in Italy is - at
      the current date - 7.6 % with an expected death of 0.004 of the whole population. The late
      lethality - still little known - from COVID-19 is to be correlated with mental disorders from
      stress response emerging from the first three COVID-19's stages and which result in a
      significant increase in suicides that is estimated at 30% more than expected of 7.4 deaths
      for 100,000 residents. This estimate can be considered as stage 4 of the disease or post
      COVID-19 mortality. In this scenario, mortality of COVID-19 is by intensity response of "the
      host " and in the meantime, a cutoff for homecare, hospitalization and time-related stress
      disease. Lines of evidence reports that direct-indirect stimulation of vagus nerve bring to
      the modulating of pro-inflammatory cytokines with effective systemic anti-inflammatory effect
      and has shown antidepressant effects in chronic treatment resistant depression. Because the
      vagus nerve is linked to brain regions important in anxiety regulation (locus coeruleus,
      orbitofrontal cortex, insula, hippocampus and amygdala), this pathway is involved in
      perceiving various somatic and cognitive symptoms that characterize anxiety and mental
      disorder disorders. On the basis of all these reasoning we plan to introduce a medical
      based-yoga deep breathing for activation of vagus nerve by scalene and sternocleidomastoid
      muscles function during breathing, as an adjuvant of care of the 1-2 and 4 stages of the
      COVID-19 disease to counteract the cumulative incidence of mortality and better outcome.
      Medical yoga protocol has been developed and designed to test a cost-effective care
      provision, training, contact tracing and mass efficacy testing.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort study based on clinical assessment. Model- based adjusted outcome via hierarchical comparison of control curves using COVID19 national epidemic data with cyber layer algorithm of population
primary purpose: Supportive Care
masking: None (Open Label)
masking description: identifier number (ID) without any refer to clinical assessment or to patients
measure: Mortality
time frame: 12 months.
description: COVID-19's Patients mortality all cause: incidence proportion.
measure: Mortality-suicide
time frame: 12 months.
description: COVID-19's Patients suicide: incidence proportion.
measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients-
time frame: 1 months.
description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder.
time frame: 12 months.
description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).
time frame: 12 months.
description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).
time frame: 12 months.
description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
arm group label: Yoga-based breathing support
arm group type: Experimental
description: Three daily yoga pranayama breathing cycles within existing home-care provision of Covid19's patients (protocols shared dated 27 March 2020 by Italian Society of Infectious and Tropical Diseases - Italian General Practitioners Physician - Italian Society of General Medicine, Italy)
intervention type: Behavioral
intervention name: morning Yoga-based breathing support
description: Low and deep inspiration and phonetic syllable OM laryngeal vibration ( OM technique) as expiratory exercises, sitting in easy pose. The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Bhramari pranayama n° of 5 RAc.
arm group label: Yoga-based breathing support
other name: First procedure
intervention type: Behavioral
intervention name: pre_lunch Yoga-based breathing support
description: Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Surya Bheda pranayama n° of 5 RAc.
arm group label: Yoga-based breathing support
other name: Second procedure
intervention type: Behavioral
intervention name: pre_dinner Yoga-based breathing support
description: Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Nadi Shodhana pranayama n° of 5 RAc.
arm group label: Yoga-based breathing support
other name: Third procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nagarathna Raghuram, MD
role: Principal Investigator
affiliation: Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
last name: HR Nagendra., Eng
role: Study Chair
affiliation: Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
last name: Maria Donatella Barbagallo, MD
role: Principal Investigator
affiliation: Yoga Experience Association,Cervia (Ra), Italy
last name: Enrico Ricci, MD
role: Principal Investigator
affiliation: Yoga Experience Association,Cervia (Ra), Italy
last name: Morena Gaddoni, MD
role: Principal Investigator
affiliation: Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
last name: Maria Luisa Vitobello
role: Study Director
affiliation: EJTN GEIE, Brussellese, Belgium
last name: Luca Ghetti, Eng.
role: Study Director
affiliation: Halnet Srl
last name: Fabio Zucchetta, MD
role: Principal Investigator
affiliation: Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
last name: Giorgio Noera, MD, PhD
phone: +393358294727
email: presidenza@healthricercaesviluppo.it
last name: Boris Bazzani, ERYT
phone: +393384841931
email: amministrazione@fbiteam.it
facility: 
contact: 
country: Italy
citation: Wenham C, Smith J, Morgan R; Gender and COVID-19 Working Group. COVID-19: the gendered impacts of the outbreak. Lancet. 2020 Mar 14;395(10227):846-848. doi: 10.1016/S0140-6736(20)30526-2. Epub 2020 Mar 6. No abstract available.
PMID: 32151325
citation: Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5. Erratum In: Crit Care. 2017 Jul 13;21(1):187.
PMID: 28179016
citation: Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.
PMID: 10839541
citation: Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. Epub 2016 Jul 5.
PMID: 27382171
citation: Thayer JF, Sternberg EM. Neural aspects of immunomodulation: focus on the vagus nerve. Brain Behav Immun. 2010 Nov;24(8):1223-8. doi: 10.1016/j.bbi.2010.07.247. Epub 2010 Jul 30.
PMID: 20674737
citation: Lv H, Zhao YH, Chen JG, Wang DY, Chen H. Vagus Nerve Stimulation for Depression: A Systematic Review. Front Psychol. 2019 Jan 31;10:64. doi: 10.3389/fpsyg.2019.00064. eCollection 2019.
PMID: 30766497
citation: O'Reardon JP, Cristancho P, Peshek AD. Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the Brainstem and Beyond. Psychiatry (Edgmont). 2006 May;3(5):54-63.
PMID: 21103178
citation: Jordana J, Trivino-Salazar JC. Where are the ECDC and the EU-wide responses in the COVID-19 pandemic? Lancet. 2020 May 23;395(10237):1611-1612. doi: 10.1016/S0140-6736(20)31132-6. Epub 2020 May 13. No abstract available.
PMID: 32410757
citation: Zhu S, Wu Y, Zhu CY, Hong WC, Yu ZX, Chen ZK, Chen ZL, Jiang DG, Wang YG. The immediate mental health impacts of the COVID-19 pandemic among people with or without quarantine managements. Brain Behav Immun. 2020 Jul;87:56-58. doi: 10.1016/j.bbi.2020.04.045. Epub 2020 Apr 18.
PMID: 32315758
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Cytokine Release Syndrome
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: Yes
ipd description: The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 18 months
ipd access criteria: ID (nikname ) and password
ipd url: https://ifc.cnr.it
study doc: 
study doc: 
study doc: 