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Yoga Pranayama Adjuvant to Treat Burden COVID-19 (YOCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413747
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : August 7, 2020
Sponsor:
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
Information provided by (Responsible Party):
Health Ricerca e Sviluppo S.R.L.

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Cytokine Storm Mental Disorder Behavioral: morning Yoga-based breathing support Behavioral: pre_lunch Yoga-based breathing support Behavioral: pre_dinner Yoga-based breathing support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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
Masking: None (Open Label)
Masking Description: identifier number (ID) without any refer to clinical assessment or to patients
Primary Purpose: Supportive Care
Official Title: Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
Estimated Study Start Date : August 15, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Yoga-based breathing support
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)
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




Primary Outcome Measures :
  1. Mortality [ Time Frame: 12 months. ]
    COVID-19's Patients mortality all cause: incidence proportion.

  2. Mortality-suicide [ Time Frame: 12 months. ]
    COVID-19's Patients suicide: incidence proportion.


Secondary Outcome Measures :
  1. Incidence of hospitalization for respiratory failure of COVID-19's Patients- [ Time Frame: 1 months. ]
    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 -

  2. Incidence of al home professional psychiatric-psychological interventions for mental disorder. [ Time Frame: 12 months. ]
    Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.

  3. Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II). [ Time Frame: 12 months. ]
    Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.

  4. Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI). [ Time Frame: 12 months. ]
    Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413747


Contacts
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Contact: Giorgio Noera, MD, PhD +393358294727 presidenza@healthricercaesviluppo.it
Contact: Boris Bazzani, ERYT +393384841931 amministrazione@fbiteam.it

Locations
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Italy
Ambulatorio Telemedicina Giardino St Lucia
Massa Lombarda, Ravenna, Italy, 48024
Contact: Morena Gaddoni    +39054581871    direzione@giardinostlucia.it   
Sponsors and Collaborators
Health Ricerca e Sviluppo S.R.L.
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
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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
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: guest_1
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: guest_2
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: guest_3

Publications:

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Responsible Party: Health Ricerca e Sviluppo S.R.L.
ClinicalTrials.gov Identifier: NCT04413747    
Other Study ID Numbers: 2020_COVID-19_YOGA
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 18 months
Access Criteria: ID (nikname ) and password
URL: https://ifc.cnr.it

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Health Ricerca e Sviluppo S.R.L.:
COVID-19
CYTOKINE STORM
MEDICAL YOGA PRANAYAMA
VAGUS NERVE STIMOLATION
MENTAL DISORDER
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Mental Disorders
Psychotic Disorders
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Respiratory Tract Infections
Respiratory Tract Diseases