跳至主要内容
临床试验/NCT04413747
NCT04413747Unknown不适用

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

Health Ricerca e Sviluppo S.R.L.2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

identifier number (ID) without any refer to clinical assessment or to patients

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Mortality

时间窗: 12 months.

COVID-19's Patients mortality all cause: incidence proportion.

Mortality-suicide

时间窗: 12 months.

COVID-19's Patients suicide: incidence proportion.

次要结局

  • Incidence of hospitalization for respiratory failure of COVID-19's Patients-(1 months.)
  • Incidence of al home professional psychiatric-psychological interventions for mental disorder.(12 months.)
  • Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).(12 months.)
  • Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).(12 months.)

研究者

发起方
Health Ricerca e Sviluppo S.R.L.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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