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

Primary Purpose

Syncope, Vasovagal

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Dhanunjaya Lakkireddy, MD, FACC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope, Vasovagal focused on measuring Neurocardiogenic Syncope, Yoga

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal spells pre and post Yoga.
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal spells pre and post Yoga.
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal symptoms pre and post Yoga.

Secondary Outcome Measures

Change in Heart Health

Full Information

First Posted
July 5, 2012
Last Updated
June 27, 2015
Sponsor
Dhanunjaya Lakkireddy, MD, FACC
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1. Study Identification

Unique Protocol Identification Number
NCT01695525
Brief Title
Influence of Yoga in Patients With Neurocardiogenic Syncope
Acronym
SYNC - YOGA
Official Title
Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dhanunjaya Lakkireddy, MD, FACC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Neurocardiogenic Syncope, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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 Outcome Measure Information:
Title
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Description
Differences in the incidence of syncopal spells pre and post Yoga.
Time Frame
Baseline to 3 Months
Title
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Description
Differences in the incidence of syncopal spells pre and post Yoga.
Time Frame
Baseline to 1 Year
Title
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Description
Differences in the incidence of syncopal symptoms pre and post Yoga.
Time Frame
Baseline to 1 Year
Secondary Outcome Measure Information:
Title
Change in Heart Health
Time Frame
3 Months, 1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD, FACC
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Influence of Yoga in Patients With Neurocardiogenic Syncope

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