Syncope, VasovagalEarly Phase 1SYNC - YOGANCT01695525
Influence of Yoga in Patients With Neurocardiogenic Syncope
A Early Phase 1 study testing Yoga in people with Syncope, Vasovagal, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of recurrent Neurocardiogenic syncope
- At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction
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.
- Conditions
- Syncope, Vasovagal
- Being tested
- Yoga
- Keywords
- Neurocardiogenic Syncope, Yoga
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 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. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal spells pre and post Yoga.
Measured: Baseline to 3 Months
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal spells pre and post Yoga.
Measured: Baseline to 1 Year
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS)
Differences in the incidence of syncopal symptoms pre and post Yoga.
Measured: Baseline to 1 Year
Secondary outcomes (1)
Change in Heart Health
Measured: 3 Months, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
- Investigators
- Dhanunjaya Lakkireddy, MD, FACC, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695525
- Sponsor's protocol ID
- 12945
- Acronym
- SYNC - YOGA
- Status last verified
- Jun 2015
- First submitted
- 5 Jul 2012
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocardiogenic Syncope and the Role That Yoga Plays in People With Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT01695525
- Acronym / sponsor ID
- SYNC - YOGA / 12945
- Conditions
- Syncope, Vasovagal
- Keywords
- Neurocardiogenic Syncope, Yoga
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of recurrent Neurocardiogenic syncope
- At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaIncludes 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. | Other | Yoga |
Primary outcome
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.
1 secondary outcome
Change in Heart Health
Time frame: 3 Months, 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy, MD, FACC principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yoga in people with Syncope, Vasovagal, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of recurrent syncopal spells in patients with Neurocardiogenic syncope (NCS) (time frame: Baseline to 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.