Influence of Yoga in Patients With Neurocardiogenic Syncope (SYNC - YOGA)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Change in Heart Health [ Time Frame: 3 Months, 1 Year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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.

Contacts and Locations

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Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

Dhanunjaya Lakkireddy, MD, FACC

Investigators

Principal Investigator:	Dhanunjaya Lakkireddy, MD, FACC	University of Kansas Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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