Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coronavirus Infection
  • Cytokine Storm
  • Mental Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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 populationMasking: None (Open Label)Masking Description: identifier number (ID) without any refer to clinical assessment or to patientsPrimary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

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 ...

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.

Tracking Information

NCT #
NCT04413747
Collaborators
  • Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India
  • Yoga Experience Association,Cervia (Ra), Italy
  • EJTN GEIE, Brussellese, Belgium
  • Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy
  • Halnet Srl, Faenza (Ra), Italy
Investigators
Principal Investigator: Nagarathna Raghuram, MD Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India Study Chair: HR Nagendra., Eng Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India Principal Investigator: Maria Donatella Barbagallo, MD Yoga Experience Association,Cervia (Ra), Italy Principal Investigator: Enrico Ricci, MD Yoga Experience Association,Cervia (Ra), Italy Principal Investigator: Morena Gaddoni, MD Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy Study Director: Maria Luisa Vitobello EJTN GEIE, Brussellese, Belgium Study Director: Luca Ghetti, Eng. Halnet Srl Principal Investigator: Fabio Zucchetta, MD Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy