Clinical trial NCT04413747: Yoga Pranayama Adjuvant to Treat Burden COVID-19
Official title: Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infection
Cytokine Storm
Mental Disorder
Keywords: COVID-19
CYTOKINE STORM
MEDICAL YOGA PRANAYAMA
VAGUS NERVE STIMOLATION
MENTAL DISORDER
Lead sponsor: Health Ricerca e Sviluppo S.R.L.
Sponsor class: INDUSTRY
Collaborators: name: Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India
name: Yoga Experience Association,Cervia (Ra), Italy
name: EJTN GEIE, Brussellese, Belgium
name: Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy
name: Halnet Srl, Faenza (Ra), Italy
First posted: 2020-06-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial;
* Male or Female, aged 18 years or above;
* Diagnosed COVID-19's infection;
* Informed consent;
* Having been diagnosed in the last 1 week;
* In the Investigator's opinion, is able and willing to comply with all trial requirements;
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial;
* Patients who continue to be followed at home.

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

* No informed consent;
* Participant is not willing and able to give informed consent for participation in the trial;
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial;
* Hospitalization patients;
* Having a serious cognitive impairment;
* Having serious hearing and vision problems;
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Primary outcomes:
measure: Mortality
timeFrame: 12 months.
measure: Mortality-suicide
timeFrame: 12 months.
Secondary outcomes:
measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients-
timeFrame: 1 months.
measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder.
timeFrame: 12 months.
measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).
timeFrame: 12 months.
measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).
timeFrame: 12 months.
Other outcomes:
Locations:
city: Massa Lombarda
country: Italy
facility: Ambulatorio Telemedicina Giardino St Lucia
state: Ravenna
Study officials:
affiliation: Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
name: Nagarathna Raghuram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
name: HR Nagendra., Eng
role: STUDY_CHAIR
affiliation: Yoga Experience Association,Cervia (Ra), Italy
name: Maria Donatella Barbagallo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yoga Experience Association,Cervia (Ra), Italy
name: Enrico Ricci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
name: Morena Gaddoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EJTN GEIE, Brussellese, Belgium
name: Maria Luisa Vitobello
role: STUDY_DIRECTOR
affiliation: Halnet Srl
name: Luca Ghetti, Eng.
role: STUDY_DIRECTOR
affiliation: Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
name: Fabio Zucchetta, MD
role: PRINCIPAL_INVESTIGATOR
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