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OpenTrials
Completed

NCT Number: NCT01695525

Influence of Yoga in Patients With Neurocardiogenic Syncope

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.

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Key information

Conditions

Syncope, Vasovagal Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Unconsciousness

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

yoga

Other

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.

Primary outcomes

  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 outcomes

  1. Change in Heart Health

    Time frame: 3 Months, 1 Year

Sponsors and collaborators

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC

Other

Registry information

Official study title

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

Acronym: SYNC - YOGA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2012
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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