Coronavirus InfectionYOCONCT04413747
Yoga Pranayama Adjuvant to Treat Burden COVID-19
A study testing morning Yoga-based breathing support, pre_lunch Yoga-based breathing support and pre_dinner Yoga-based breathing support in people with Coronavirus Infection and Cytokine Storm, run by Health Ricerca e Sviluppo S.R.L. at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Infection, Cytokine Storm, Mental Disorder
- What is being tested?
- morning Yoga-based breathing support, pre_lunch Yoga-based breathing support and pre_dinner Yoga-based breathing support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Aug 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ambulatorio Telemedicina Giardino St Lucia
Massa Lombarda, Ravenna, 48024
Morena Gaddoni, +39054581871, direzione@giardinostlucia.it
About this study
Official title: Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
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.
Read the 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.
- Conditions
- Coronavirus Infection, Cytokine Storm, Mental Disorder
- Being tested
- morning Yoga-based breathing support, pre_lunch Yoga-based breathing support, pre_dinner Yoga-based breathing support
- Keywords
- COVID-19, CYTOKINE STORM, MEDICAL YOGA PRANAYAMA, VAGUS NERVE STIMOLATION, MENTAL DISORDER
- Medical subject headings
- Coronavirus Infections, Cytokine Release Syndrome, Mental Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morning Yoga-based breathing supportBehavioural
Also called First procedure
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 supportBehavioural
Also called Second procedure
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 supportBehavioural
Also called Third procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga-based breathing support | Experimental | 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) Receives: Behavioral: morning Yoga-based breathing support; Behavioral: pre_lunch Yoga-based breathing support; Behavioral: pre_dinner Yoga-based breathing support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
COVID-19's Patients mortality all cause: incidence proportion.
Measured: 12 months.
Mortality-suicide
COVID-19's Patients suicide: incidence proportion.
Measured: 12 months.
Secondary outcomes (4)
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 -
Measured: 1 months.
Incidence of al home professional psychiatric-psychological interventions for mental disorder.
Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Measured: 12 months.
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.
Measured: 12 months.
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.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Aug 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Ricerca e Sviluppo S.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Nagarathna Raghuram, MD, Principal investigator, Vivekananda Yoga Anusandhana Samsthana, Bengaluru, IndiaHR Nagendra., Eng, Study chair, Vivekananda Yoga Anusandhana Samsthana, Bengaluru, IndiaMaria Donatella Barbagallo, MD, Principal investigator, Yoga Experience Association,Cervia (Ra), ItalyEnrico Ricci, MD, Principal investigator, Yoga Experience Association,Cervia (Ra), ItalyMorena Gaddoni, MD, Principal investigator, Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) ItalyMaria Luisa Vitobello, Study director, EJTN GEIE, Brussellese, BelgiumLuca Ghetti, Eng., Study director, Halnet SrlFabio Zucchetta, MD, Principal investigator, Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413747
- Sponsor's protocol ID
- 2020_COVID-19_YOGA
- Acronym
- YOCO
- Status last verified
- Aug 2020
- First submitted
- 29 May 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be available upon request within a web\_ client structure
Publications
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. No abstract available.
PubMed 32151325Johansson 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.
PubMed 28179016Borovikova 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. doi: 10.1038/35013070.
PubMed 10839541Koopman 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.
PubMed 27382171Thayer 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.
PubMed 20674737Lv 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.
PubMed 30766497O'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.
PubMed 21103178Jordana J, Trivino-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. No abstract available.
PubMed 32410757Zhu 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.
PubMed 32315758
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
- ClinicalTrials.gov ID
- NCT04413747
- Acronym / sponsor ID
- YOCO / 2020_COVID-19_YOGA
- Conditions
- Coronavirus Infection, Cytokine Storm, Mental Disorder
- Keywords
- COVID-19, CYTOKINE STORM, MEDICAL YOGA PRANAYAMA, VAGUS NERVE STIMOLATION, MENTAL DISORDER
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Health Ricerca e Sviluppo S.R.L.Industry (pharma, biotech, devices)
- 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
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Yoga-based breathing support | Experimental | Behavioral: morning Yoga-based breathing support, Behavioral: pre_lunch Yoga-based breathing support, Behavioral: pre_dinner Yoga-based breathing supportThree 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morning Yoga-based breathing supportAlso: First procedureLow 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. | Behavioural | Yoga-based breathing support |
| pre_lunch Yoga-based breathing supportAlso: Second procedureLow 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. | Behavioural | Yoga-based breathing support |
| pre_dinner Yoga-based breathing supportAlso: Third procedureLow 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. | Behavioural | Yoga-based breathing support |
Primary outcome
Mortality
Time frame: 12 months.
COVID-19's Patients mortality all cause: incidence proportion.
Mortality-suicide
Time frame: 12 months.
COVID-19's Patients suicide: incidence proportion.
4 secondary outcomes
Incidence of hospitalization for respiratory failure of COVID-19's Patients-
Time frame: 1 months.
Incidence of al home professional psychiatric-psychological interventions for mental disorder.
Time frame: 12 months.
Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).
Time frame: 12 months.
Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 32151325Wenham 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. No abstract available.
- Background: PubMed 28179016Johansson 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.
- Background: PubMed 10839541Borovikova 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. doi: 10.1038/35013070.
- Background: PubMed 27382171Koopman 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.
- Background: PubMed 20674737Thayer 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.
- Background: PubMed 30766497Lv 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.
- Background: PubMed 21103178O'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.
- Background: PubMed 32410757Jordana J, Trivino-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. No abstract available.
- Background: PubMed 32315758Zhu 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.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagarathna Raghuram, MD principal investigator
Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
HR Nagendra., Eng study chair
Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
Maria Donatella Barbagallo, MD principal investigator
Yoga Experience Association,Cervia (Ra), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morning Yoga-based breathing support, pre_lunch Yoga-based breathing support and pre_dinner Yoga-based breathing support in people with Coronavirus Infection and Cytokine Storm, run by Health Ricerca e Sviluppo S.R.L. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Noera, MD, PhD (+393358294727, presidenza@healthricercaesviluppo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413747, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.