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Syncope, Vasovagal | Influence of Yoga in Patients With Neurocardiogenic Syncope

Syncope, Vasovagal research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of recurrent Neurocardiogenic syncope - At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment Exclusion Criteria: - 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: 1. Pregnant women 2. Subjects with untreated or uncontrolled high blood pressure 3. Subjects with past history of Pnuemothorax. 4. Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse. 5. Subjects with carotid stenosis 6. Subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse. 7. Subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation) 8. Subjects with glaucoma 9. Subjects with history of Total Hip Replacement.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope, Vasovagal

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:YogaIncludes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

YogaParticipants will be asked to practice Yoga 3 times per week at a minimum, and daily at a maximum. Participants will receive training in different Yoga techniques including breathing exercises, postures and meditation. Participants will be asked to practice 1 hour Yoga sessions comprised of breathing exercises, postures and meditation.

Study Status

Completed

Start Date: June 2012

Completed Date: March 2015

Phase: Early Phase 1

Type: Interventional

Design:

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

Secondary Outcome: Change in Heart Health

Study sponsors, principal investigator, and references

Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC

Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01695525

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