Official Title
Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
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.

Unknown status
Coronavirus Infection
Cytokine Storm
Mental Disorder

Behavioral: morning Yoga-based breathing support

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.
Other Name: First procedure

Behavioral: pre_lunch Yoga-based breathing support

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.
Other Name: Second procedure

Behavioral: pre_dinner Yoga-based breathing support

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.
Other Name: Third procedure

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Italy
Locations

Ambulatorio Telemedicina Giardino St Lucia
Massa Lombarda, Ravenna, Italy

Investigator: Morena Gaddoni
Contact: +39054581871
direzione@giardinostlucia.it

Contacts

Giorgio Noera, MD, PhD
+393358294727
presidenza@healthricercaesviluppo.it

Boris Bazzani, ERYT
+393384841931
amministrazione@fbiteam.it

Health Ricerca e Sviluppo S.R.L.
NCT Number
Keywords
Covid-19
Cytokine storm
MEDICAL YOGA PRANAYAMA
VAGUS NERVE STIMOLATION
MENTAL DISORDER
MeSH Terms
COVID-19
Coronavirus Infections
Cytokine Release Syndrome
Mental Disorders
Psychotic Disorders