Clinical trial NCT01695525: Influence of Yoga in Patients With Neurocardiogenic Syncope
Official title: Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Syncope, Vasovagal
Keywords: Neurocardiogenic Syncope
Yoga
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
timeFrame: Baseline to 3 Months
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
timeFrame: Baseline to 1 Year
measure: Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
timeFrame: Baseline to 1 Year
Secondary outcomes:
measure: Change in Heart Health
timeFrame: 3 Months, 1 Year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: