Influence of Yoga in Patients With Neurocardiogenic Syncope (SYNC - YOGA)
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ClinicalTrials.gov Identifier: NCT01695525 |
Recruitment Status
:
Completed
First Posted
: September 28, 2012
Last Update Posted
: June 30, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Syncope, Vasovagal | Other: Yoga | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Yoga
Participants 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.
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Other: Yoga
Includes 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.
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- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 3 Months ]Differences in the incidence of syncopal spells pre and post Yoga.
- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 1 Year ]Differences in the incidence of syncopal spells pre and post Yoga.
- Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) [ Time Frame: Baseline to 1 Year ]Differences in the incidence of syncopal symptoms pre and post Yoga.
- Change in Heart Health [ Time Frame: 3 Months, 1 Year ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695525
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Dhanunjaya Lakkireddy, MD, FACC | University of Kansas Medical Center |
Responsible Party: | Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center Research Institute |
ClinicalTrials.gov Identifier: | NCT01695525 History of Changes |
Other Study ID Numbers: |
12945 |
First Posted: | September 28, 2012 Key Record Dates |
Last Update Posted: | June 30, 2015 |
Last Verified: | June 2015 |
Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute:
Neurocardiogenic Syncope Yoga |
Additional relevant MeSH terms:
Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases |