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临床试验/NCT01695525
NCT01695525已完成早期 1 期

Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction

Dhanunjaya Lakkireddy, MD, FACC2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)

研究概览

简要总结

Syncope is a common problem that many clinicians may encounter in various outpatient settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self limited episode of systemic hypotension. Patients are usually managed with education on syncope, anxiety management, and coping skills.

It has been established that practice of Yoga could relieve stress and anxiety. In a different study, they also found that Yoga positively influences cardiovascular function by decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve control over the autonomic nervous system and able to control functions like heart rate, blood pressure and respiratory rate.

Based on the findings that Yoga relieves stress and reduces heart rate, the investigators propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms associated with these episodes.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of recurrent Neurocardiogenic syncope
  • At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment

排除标准

  • Previously established diagnosis of any psychiatric illness.
  • Previous history of Coronary Artery Disease, myocardial infarction, congestive heart failure, carotid sinus hypersensitivity
  • Established diagnosis of tachy and/or brady arrhythmias, except cardioinhibiotry neurocardiogenic syncope.
  • History of pacemaker, ICD or CRT-D implantation.
  • Other conditions where Yoga should be avoided are:
  • Pregnant women
  • Subjects with untreated or uncontrolled high blood pressure
  • Subjects with past history of Pnuemothorax.
  • Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse.
  • Subjects with carotid stenosis
  • Subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse.
  • Subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation)
  • Subjects with glaucoma
  • Subjects with history of Total Hip Replacement.

结局指标

主要结局

Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)

时间窗: Baseline to 1 Year

Differences in the incidence of syncopal spells pre and post Yoga.

次要结局

  • Change in Heart Health(3 Months, 1 Year)

研究者

发起方
Dhanunjaya Lakkireddy, MD, FACC
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dhanunjaya Lakkireddy, MD, FACC

Professor of Medicine

University of Kansas Medical Center

研究点 (2)

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