Yoga Pranayama Adjuvant to Treat Burden COVID-19

Coronavirus Infection Clinical Trial

— YOCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04413747
• Other study ID #: 2020_COVID-19_YOGA
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: Health Ricerca e Sviluppo S.R.L.
• Contact: Giorgio Noera, MD, PhD
• Phone: +393358294727
• Email: presidenza[@]healthricercaesviluppo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Cytokine Storm
• Mental Disorder
• Mental Disorders
• Psychotic Disorders
• Severe Acute Respiratory Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Ambulatorio Telemedicina Giardino St Lucia	Massa Lombarda	Ravenna

Sponsors (6)

Lead Sponsor	Collaborator
Health Ricerca e Sviluppo S.R.L.	Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy, EJTN GEIE, Brussellese, Belgium, Halnet Srl, Faenza (Ra), Italy, Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India, Yoga Experience Association,Cervia (Ra), Italy

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View 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. Review. Erratum in: Crit Care. 2017 Jul 13;21(1):187. — View Citation

Jordana J, Triviño-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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	COVID-19's Patients mortality all cause: incidence proportion.	12 months.
Primary	Mortality-suicide	COVID-19's Patients suicide: incidence proportion.	12 months.
Secondary	Incidence of hospitalization for respiratory failure of COVID-19's Patients-	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 -	1 months.
Secondary	Incidence of al home professional psychiatric-psychological interventions for mental disorder.	Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.	12 months.
Secondary	Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).	Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.	12 months.
Secondary	Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).	Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.	12 months.